COLINA

COLINA bag 3 g powder for manufacturing suspension for use.

Important notes (mandatory information)

Colina 3 g, powder. Active ingredient: Smectite. Areas of application: for the symptomatic treatment of acute diarrhoea.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Colina 3 g, powder for oral suspension Smectite (dioctahedral)

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Colina must be used as directed to ensure the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 3 days, you must see a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS COLINA AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING COLINA?
3. HOW TO TAKE COLINA?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE COLINA?
6. FURTHER INFORMATION

1. WHAT IS COLINA AND WHAT IS IT USED FOR?

Colina is a gastrointestinal therapeutic. The active ingredient is smectite (dioctahedral), a purified natural, three-layer clay mineral. Colina is used for the symptomatic treatment of acute diarrhoea.

2. WHAT YOU NEED TO KNOW BEFORE TAKING COLINA?

Colina must not be taken if you are hypersensitive (allergic) to smectite (dioctahedral), soya, peanuts or any of the other ingredients of Colina.

Special care must be taken when taking Colina:

• if you have suffered from severe chronic constipation in the past.
• In children: Always ensure adequate fluid intake. To avoid dehydration, treatment in children should always be combined with oral electrolyte supplementation. If necessary, this should also be done in adults during

When taking Colina with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. The binding capacity of smectite (dioctahedral) can affect the absorption of other medicines. Therefore, it is not recommended to take other medicines at the same time. Always take other medicines 1 1/2 hours before or after taking Colina.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicines. If used as directed, you can take Colina during pregnancy and breast-feeding after consulting your doctor.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Colina

This medicine contains glucose and sucrose. Please only take Colina after consulting your doctor if you know that you suffer from an intolerance to certain sugars (e.g. fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency). Colina contains sodium, but less than 1 mmol (23 mg) sodium per sachet, i.e. it is virtually "sodium-free".

3. HOW TO TAKE COLINA?

Always take Colina exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Children: Children under 1 year: 2 sachets daily (1 sachet in the morning, 1 sachet in the evening) for up to 3 days, then 1 sachet daily. Children over 1 year: 4 sachets daily (approximately every 4 hours) for up to 3 days, then 2 sachets daily (1 sachet in the morning, 1 sachet in the evening). The dose should be adjusted according to the development of the symptoms. The total duration of treatment should not exceed 7 days without medical advice. Adults: 6 sachets daily (2 sachets in the morning, 2 sachets at midday, 2 sachets in the evening) for up to 4 days, which can be reduced to 3 sachets depending on the development of the symptoms. The total duration of treatment should not exceed 7 days without medical advice. The contents of the sachets must be dissolved before taking and taken immediately. After standing for a while, stir again thoroughly so that the powder does not settle at the bottom. It is preferable to take it between meals. For children, please use either 50 ml of water (e.g. in a feeding bottle) or mix the powder with semi-liquid food (e.g. ready-made baby food, vegetable or fruit puree, soup). When taking smectite (dioctahedral), children must always be given sufficient fluids (see section 2. What you need to know before taking Colina?). In adults, the powder can be stirred into half a glass of water or semi-liquid food. Please talk to your doctor or pharmacist if you feel that the effect of Colina is too strong or too weak. If you have taken more Colina than you should, you may experience severe constipation and stomach stones. Please contact a doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Colina can have side effects, although not everybody gets them. The following list of adverse effects includes all known adverse effects under treatment with smectite (dioctahedral). The following frequency categories are used to assess side effects

The following frequency categories are used to assess side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Gastrointestinal tract

Uncommon: Transient constipation, which subsides after individual adjustment of the dosage.

Other side effects observed after the medicine was placed on the market: Very rarely, hypersensitivity reactions of the skin have been reported, including hives, rash, itching or swelling (angioedema).

Other possible side effects

Colina can very rarely cause allergic reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE COLINA?

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the sachets and the outer carton after "Use by:". The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

6. FURTHER INFORMATION

What Colina contains

The active ingredient is smectite (dioctahedral). 1 sachet containing 3.760 g of powder for oral suspension contains 3.00 g of smectite (dioctahedral). The other ingredients are: Glucose monohydrate (Ph.Eur.), saccharin sodium, vanilla flavouring*, orange flavouring**. *Composition of vanilla flavouring: maltodextrin, sucrose, triacetin (E1518), silicon dioxide hydrate (E551), ethanol, (3-sn-phosphatidyl)choline from soya beans (E322), vanilla flavourings. **Composition of orange flavouring: maltodextrin, sucrose, gum arabic (E414), mono- and diacetyl tartaric acid esters of mono- and diglycerides of edible fatty acids (E472e), silicon dioxide hydrate (E551), orange oils.

What Colina looks like and contents of the pack

One sachet (a single dose) contains a whitish to slightly beige powder with a slight orange smell. Colina is available in packs of 10 and 20 sachets.

Pharmaceutical entrepreneur:
Ipsen Pharma GmbH
76275 Ettlingen
Tel.: 07243 184-80
Fax: 07243 184-39

Manufacturer

Beaufour Ipsen Industrie
F-28100 Dreux

This package leaflet was last revised in May 2015.

Source: Information from the package leaflet
Status: 12/2016
Active ingredient: Smectite. Areas of application: for the symptomatic treatment of acute diarrhoea.