october 2012 agiolax saudi arabia (approved) / saudi ... · package leaflet: information for the...

Approved combined label and PIL text Proposed PIL text

Mat. Code no.: 229 196 Mat. Code no.:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Agiolax® Granules MADAUS

A plant preparation for regulating bowel function. 1. WHAT AGIOLAX® IS AND WHAT IT IS USED FOR

Pharmacotherapeutic group:

Agiolax® is a stimulant laxative of plant origin.

Important information, please read carefully! Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor, health care provider or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their

symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell

your doctor, health care provider or pharmacist.

Composition: 100 g of the granules contain

Seeds of Plantago ovata 52.0 g

Ispaghula husk 2.2 g

Tinnevelly Senna pods 12.4 g

6. FURTHER INFORMATION

a) What Agiolax® contains:

- The active substances are:

5 g granules (= 1 teaspoonful) contain:

Ispaghula seed 2.60 g

Ispaghula husk 0.11 g

Tinnevelly senna pods 0.34-0.66 g

equivalent to 15 mg hydroxyanthracene derivatives calculated as sennoside B.

- The other ingredients are:

Talc, gum arabic, iron oxides, hard paraffin, liquid paraffin, aromatics, sucrose (sugar).

1 teaspoonful contains approx. 1.05 g sucrose (sugar) equivalent to 0.09 bread units (BU).

Properties: Agiolax regulates the functioning of the bowel in a natural way. Its action is

based on vegetable mucilages which swell up on contact with water to

produce a soft and easily passed stool. The senna pods have a

supplementary effect in cases where the bowels tend to be sluggish.

Agiolax does not cause any undesirable side-effects.

Therapeutic indications: Area of indications:

Acute and chronic constipation

It is particularly suitable for bowel regulation in bed-ridden patients, during

pregnancy and post partum. It is also useful for ensuring painfree evacuation

in cases of haemorrhoids.

1. WHAT AGIOLAX® IS AND WHAT IT IS USED FOR

Pharmacotherapeutic group:

Agiolax® is a stimulant laxative of plant origin.

Therapeutic indication:

For short-term use in constipation.

Agiolax

Saudi Arabia (approved) / Saudi Arabia (proposed)

October 2012

C:\Documents and Settings\Fakhry\Desktop\Agiolax\Module 1\1.3 Product Information\1.3.3 PIL\2012-10_PIL_comp-table_old-proposed

Dosage and administration: Agiolax should be swallowed unchewed with a sufficient amount of fluid, e.g.

in the evening a cup of tea or in the morning a glass of cold water. Unless

otherwise directed by the doctor we recommend the following dosages:

Adults: Every evening after supper and, if required, also in the morning

before breakfast 1 teaspoonful of Agiolax. In obstinate cases: 1 teaspoonful

of Agiolax every 6 hours for 1-3 days.

Children: Schoolchildren - 1 teaspoonful of Agiolax daily; 12 years and

upwards - dosage as for adults.

Pregnant women: 1 teaspoonful of Agiolax every morning or every evening.

3. HOW TO TAKE AGIOLAX®

Always take Agiolax exactly as specified in this leaflet. Please check with your doctor if you are not sure.

Unless otherwise directed by your doctor, the usual dose is:

The maximum daily intake must not exceed 30 mg hydroxyanthracene derivatives; this is equivalent to

10 g (= 2 teaspoonfuls) of Agiolax®.

Adults and children over 12 years of age take 1 to 2 teaspoonfuls Agiolax® after the evening meal.

The correct dosage for the individual patient is the smallest amount which is necessary to produce a soft but

formed stool. The laxative effect usually occurs after 8-12 hours.

Method of administration

The granules should be swallowed unchewed with an abundant amount of liquid (about ¼ litre). After taking

any other medicines, an interval of ½ - 1 hour should be adhered to.

Duration of treatment

Stimulant laxatives must not be taken for longer periods (more than 1-2 weeks) without medical advice.

a) If you take more Agiolax® than you should

In case of inadvertent or deliberate overdose there may be painful intestinal cramps and severe diarrhoea

with consequent losses of water and minerals, as well as severe gastrointestinal complaints. If you have

taken an overdose, please consult a doctor immediately. He will decide what countermeasures (e.g.,

administration of fluid and salts) may be necessary.

b) If you forget to take Agiolax®

Do not take a double dose to make up for a forgotten dose.

c) If you stop taking Agiolax®

No special precautions required.

If you have any further questions on the use of this product, ask your doctor, health care provider or

pharmacist.


This is a medicament: Incompatibilities and risks:

In cases of intestinal obstruction (ileus), Agiolax - like any other laxative - is

contra-indicated. In cases of permanent constipation the cause has to be

cleared up by the doctor.

2. BEFORE YOU TAKE AGIOLAX®

a) Do not take Agiolax®

- if you are allergic (hypersensitive) to Ispaghula seed, Ispaghula husk, Tinnevelly senna pods or any of the other

ingredients of Agiolax®,

- if you are suffering from abnormal narrowing in the gastrointestinal tract;

- if you are suffering from ileus;

- if you are suffering from diabetes mellitus which is difficult to control;

- if you are suffering from acute inflammatory conditions of the intestine, e.g., Crohn’s disease, ulcerative colitis or

appendicitis;

- if you are suffering from abdominal pain of unknown origin;

- if you are suffering from severe dehydration with water and electrolyte losses;

- in children under 12 years of age.

b) Take special care with Agiolax®

Any intake of stimulant laxatives for longer periods may worsen bowel sluggishness.

The preparation should be used only if constipation cannot be resolved by means of changes in diet or with the aid of

pure bulk preparations.

Note: When Agiolax® is taken by adult incontinent persons, prolonged contact of the skin with the faeces should be

avoided by changing sanitary towels.

c) Taking other medicines, herbal or dietary supplements

In cases of chronic use/abuse, potassium deficiency may potentiate the action of drugs

strengthening the cardiac muscle (cardiac glycosides) and may affect the action of anti-arrhythmic agents.

Potassium loss may be aggravated by combination with certain drugs which increase the urine output (diuretics),

cortisone and cortisone-like substances (adrenocortical steroids) and liquorice root.

The absorption of concomitantly taken medicines from the gastrointestinal tract into the blood stream may be

retarded. In insulin-dependent diabetics it may be necessary to reduce the insulin dose.

Please tell your doctor, health care provider or pharmacist if you are taking or have recently taking any other

medicines, including medicines obtained without a prescription.

d) Taking Agiolax® with food and drink

The granules should be swallowed unchewed with an abundant amount of liquid in the evening after the meal.

e) Pregnancy and breast-feeding

During the first three months of pregnancy Agiolax® should be used only if constipation cannot be resolved by a

change in diet or with the aid of bulking agents. Please seek the advice of your doctor.

Note:

Breakdown products of senna pods such as rhein have a laxative action and pass in small amounts into the maternal

milk. No laxative effect on breast-fed infants has been observed.

Ask your doctor, health care provider or pharmacist for advice before taking any medicines.

f) Driving and using machines

No special precautions are required.

g) Important information about some of the ingredients of Agiolax®

This medicine contains sucrose (sugar). If you know that you have allergic reactions to certain sugars, please take

Agiolax® only after consultation with your doctor.


4. POSSIBLE SIDE EFFECTS

Like all medicines, Agiolax® can cause side effects, although not everybody gets them.

Side effect rating was based on the following frequency data:

.................

Very rarely cramp-like gastrointestinal complaints. In these cases, a dose reduction is necessary. In the

course of treatment a harmless red coloration of urine may occur.

In case of long-term use or higher doses (abuse) there may be disorders in the water and electrolyte

balance. Appearance of diarrhoea may lead in particular to loss of potassium. Potassium loss can lead to

disorders of cardiac function and to muscle weakness, in particular if cardiac glycosides (drugs which

strengthen the cardiac muscle), diuretics (drugs which increase urine output) or cortisone and cortisone-like

substances (adrenocortical steroids) are being taken concurrently. In case of long-term use, protein and

blood may appear in the urine. Furthermore, deposition of pigment in the intestinal mucosa

(pseudome¬lanosis coli) may occur which, as a rule, is reversible after discontinuation of the preparation.

Very rarely, hypersensitivity reactions to the active substances can occur.

Very rarely, oesophagus obstructions can occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your

doctor, health care provider or pharmacist.

Store medicines carefully out of the reach of children! 5. HOW TO STORE AGIOLAX®

Keep out of the reach and sight of children.

Do not store above 30ºC.

Always close container after use!

Do not use Agiolax® after the expiry date which is stated on the bottom of the container after “EXP”. The

expiry date refers to the last day of that month.

Presentation form and package size:

Pack of 250 g granules

Contents 250 g granules

6.b) What Agiolax® looks like and contents of the pack:

Original packs of 100 g and 250 g brown granules (container with screw cap)

Available only in pharmacies. Available in pharmacies only.

Manufactured by

MADAUS GmbH, 51101 Köln, FRG.

6.c) Marketing authorization holder and Manufacturer

Madaus GmbH, 51101 Cologne, Germany

Tel.: +49 221 8998-0; Fax: +49 221 8998-711

Email: [email protected]

For any information about this medicinal product, please contact the local representative of the Marketing

Authorization Holder:

ANNAHDAH MEDICAL COMPANY

7th Floor, Al-Suhaily Plaza, Al-Andalus Street,

P. O. Box: 4683, Jeddah-21412

Saudi Arabia.

Phone: +966 2 6579933; Ext.: 109

Fax: +966 2 6531316

[email protected]

6.d) This leaflet was last approved in September 2012.


6.e) To report any side effects

- National Pharmacovigilance Center (NPC)

o Fax: +966-1-210-7398

o E-mail: [email protected]

o Website: www.sfda.gov.sa/npc

Council of Arab Health Ministers

This is a Medicament

- Medicament is a product which affects your health and its consumption

contrary to instructions is dangerous for you.

- Follow strictly the doctor's prescription, the method of use and the instructions

of the pharmacist who sold the medicament.

- The doctor and the pharmacist are the experts in medicines, their benefits and

risks.

- Do not by yourself interrupt the period of treatment prescribed for you.

- Do not repeat the same prescription without consulting your doctor.

- Keep all medicaments out of reach of children.


Union of Arab Pharmacists


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2012_engl_SA.rtf Page 1 of 6

Wording of data intended for the package leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER

Agiolax®

Granules

Active substances: Ispaghula seed, Ispaghula husk, Tinnevelly senna pods

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, health care provider or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.

In this leaflet:

1. What Agiolax®

is and what it is used for

2. Before you take Agiolax®

3. How to take Agiolax®

4. Possible side effects

5. How to store Agiolax®

6. Further information

1. WHAT AGIOLAX® IS AND WHAT IT IS USED FOR

Pharmacotherapeutic group: Agiolax

® is a stimulant laxative of plant origin.

Therapeutic indication:

For short-term use in constipation.

2. BEFORE YOU TAKE AGIOLAX®

a) Do not take Agiolax®

- if you are allergic (hypersensitive) to Ispaghula seed, Ispaghula husk, Tinnevelly senna pods or any of the other ingredients of Agiolax

®,



- if you are suffering from abnormal narrowing in the gastrointestinal tract;

- if you are suffering from ileus;

- if you are suffering from diabetes mellitus which is difficult to control;

- if you are suffering from acute inflammatory conditions of the intestine, e.g., Crohn’s disease, ulcerative colitis or appendicitis;

- if you are suffering from abdominal pain of unknown origin;

- if you are suffering from severe dehydration with water and electrolyte losses;

- in children under 12 years of age.

b) Take special care with Agiolax®

Any intake of stimulant laxatives for longer periods may worsen bowel sluggishness.

The preparation should be used only if constipation cannot be resolved by means of changes in diet or with the aid of pure bulk preparations.

Note: When Agiolax

® is taken by adult incontinent persons, prolonged contact of the skin

with the faeces should be avoided by changing sanitary towels.

c) Taking other medicines, herbal or dietary supplements

In case of chronic use/abuse, potassium deficiency may potentiate the action of drugs strengthening the cardiac muscle (cardiac glycosides) and may affect the action of antiar-rhythmic agents.

Potassium loss may be aggravated by combination with certain drugs which increase the urine output (diuretics), cortisone and cortisone-like substances (adrenocortical steroids) and liquorice root. The absorption of concomitantly taken medicines from the gastrointestinal tract into the blood stream may be retarded. In insulin-dependent diabetics it may be necessary to reduce the insulin dose. Please tell your doctor, health care provider or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

d) Taking Agiolax®

with food and drink

The granules should be swallowed unchewed with an abundant amount of liquid in the evening after the meal.



e) Pregnancy and breast-feeding

During the first three months of pregnancy Agiolax®

should be used only if constipation cannot be resolved by a change in diet or with the aid of bulking agents. Please seek the advice of your doctor. Note: Breakdown products of senna pods such as rhein have a laxative action and pass in small amounts into the maternal milk. No laxative effect on breast-fed infants has been observed.

Ask your doctor, health care provider or pharmacist for advice before taking any medicines.

f) Driving and using machines

No special precautions are required.

g) Important information about some of the ingredients of Agiolax®

This medicine contains sucrose (sugar). If you know that you have allergic reactions to certain sugars, please take Agiolax

® only after consultation with your

doctor.

3. HOW TO TAKE AGIOLAX®

Always take Agiolax®

exactly as specified in this leaflet. Please check with your doctor if you are not sure.

Unless otherwise directed by your doctor, the usual dose is:

The maximum daily intake must not exceed 30 mg hydroxyanthracene derivatives;

this is equivalent to 10 g ( 2 teaspoonfuls) of Agiolax®

. Adults and children over 12 years of age take 1 to 2 teaspoonfuls Agiolax

® in the

evening after the meal. The correct dosage for the individual patient is the smallest amount which is necessary to produce a soft but formed stool. The laxative effect usually occurs after 8-12 hours.

Method of administration

The granules should be swallowed unchewed with an abundant amount of liquid

(about ¼ litre). After taking any other medicines, an interval of ½ - 1 hour should be

adhered to.

Duration of treatment

Stimulant laxatives must not be taken for longer periods (more than 1-2 weeks) without medical advice.



a) If you take more Agiolax® than you should

In case of inadvertent or deliberate overdose there may be painful intestinal cramps and severe diarrhoea with consequent losses of water and minerals, as well as severe gastrointestinal complaints. If you have taken an overdose, please consult a doctor immediately. He will decide what countermeasures (e.g., administration of fluid and salts) may be necessary.

b) If you forget to take Agiolax®

Do not take a double dose to make up for a forgotten dose.

c) If you stop taking Agiolax®

No special precautions required.

If you have any further questions on the use of this product, ask your doctor, health care provider or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Agiolax®

can cause side effects, although not everybody gets them.

Side effect rating was based on the following frequency data:

Very frequent: More than 1 of 10 treated patients Frequent: 1 to 10 of 100 treated patients Occasional: 1 to 10 of 1000 treated patients Rare: 1 to 10 of 10 000 treated patients Very rare: Less than 1 of 10 000 treated patients Not known: Unassessable on the basis of data available

Very rarely cramp-like gastrointestinal complaints. In these cases, a dose reduction is necessary. In the course of treatment a harmless red coloration of urine may occur. In case of long-term use or higher doses (abuse) there may be disorders in the water and electrolyte balance. Appearance of diarrhoea may lead in particular to loss of potassium. Potassium loss can lead to disorders of cardiac function and to muscle weakness, in particular if cardiac glycosides (drugs which strengthen the cardiac muscle), diuretics (drugs which increase urine output) or cortisone and cortisone-like substances (adrenocortical steroids) are being taken concurrently. In case of long-term use, protein and blood may appear in the urine. Furthermore, deposition of pigment in

the intestinal mucosa (Pseudomelanosis coli) may occur which, as a rule, is reversible after discontinuation of the preparation.



Very rarely hypersensitivity reactions to Ispaghula can occur.

Very rarely oesophagus obstructions can occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.

5. HOW TO STORE AGIOLAX®

Keep out of the reach and sight of children.

Do not store above 30ºC. Always close container after use!

Do not use Agiolax®

after the expiry date which is stated on the bottom of the container after “EXP”. The expiry date refers to the last day of that month.

6. FURTHER INFORMATION

a) What Agiolax® contains:

- The active substances are:

- 5 g granules (= 1 teaspoonful) contains: Ispaghula seed 2.60 g Ispaghula husk 0.11 g Tinnevelly senna pods 0.34-0.66 g

equivalent to 15 mg hydroxyanthracene derivatives calculated as sennoside B.

- The other ingredients are:

Talc, gum arabic, iron oxides, hard paraffin, liquid paraffin, aromatics, sucrose (sugar). 1 teaspoonful contains approx. 1.05 g sucrose (sugar) equivalent to 0.09 bread units (BU).

b) What Agiolax® looks like and contents of the pack

Original packs of 100 g and 250 g brown granules (container with screw cap)



c) Marketing authorization holder and Manufacturer

Madaus GmbH, 51101 Cologne, Germany Tel.: +49 221 8998-0; Fax: +49 221 8998-711 Email: [email protected]

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

ANNAHDAH MEDICAL COMPANY 7th Floor, Al-Suhaily Plaza, Al-Andalus Street, P. O. Box: 4683, Jeddah-21412 Saudi Arabia. Phone: +966 2 6579933; Ext.: 109 Fax: +966 2 6531316 [email protected]

d) This leaflet was last approved in 09/2012.

e) To report any side effects

- National Pharmacovigilance Center (NPC)

o Fax: +966-1-210-7398

o E-mail: [email protected]

o Website: www.sfda.gov.sa/npc


This is a Medicament

- Medicament is a product which affects your health and its consumption

contrary to instructions is dangerous for you.

- Follow strictly the doctor's prescription, the method of use and the instructions

of the pharmacist who sold the medicament.

- The doctor and the pharmacist are the experts in medicines, their benefits and

risks.

- Do not by yourself interrupt the period of treatment prescribed for you.

- Do not repeat the same prescription without consulting your doctor.

- Keep all medicaments out of reach of children.


Union of Arab Pharmacists

mailto:[email protected]

http://www.sfda.gov.sa/npc

Agiolax

IspaghulaIspaghula

Tinnevelly

1.

2.

3.

4.

5.

6.

. شج قشاءة ىزه اننششة بعنات قبم بذء اسخخذام ىزا انذاء

احخفظ باننششة ، سبما ححخاج نقشاءحيا مشة أخش

اسأل انطبب انمعانج، أ مقذم انشعات أخشاساثفإرا كانج نذكم ا اسخس ،

.انصحت ا انصذن

سبما حسبب نيم ا ضشس، حخ ن . ىزا انذاء حم صفو نك، ال حقذمو خشن

. كانج اعشاضيم مشابيت نحانخك

ف حانت حفاقم ا آثاس جانبت، أ إرا الحظج جد أ آثاس جانبت غش مذسجت

ف ىزه اننششة، شج افادة انطبب انمعانج، ا مقذم ا نشعات انصحت، ا

. انصذالن

( أ

Tinnevelly

.

:

.

(

.

hydroxyanthracene

(‌أ

Tinnevelly

hydroxyanthracene

.

(BU)

MADAUS GmbH

[email protected]




[email protected]

(NPC)

[email protected]

www.sfda.gov.sa/npc








