1 g tablets, 200 mg / ml oral suspension, 1 g / 5 ml oral suspension, sachet 
sucralfate

Read all of this leaflet carefully before you start taking this medicine.  It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Andapsin is and what it is used for 
2. Before you take Andapsin 
3. How to use Andapsin 
4. Possible side effects 
5. How to store Andapsin 
6. Other information

1. What Andapsin is and what it is used for

Andapsin is a remedy used for stomach ulcers. It acts locally in the gastrointestinal tract and is not absorbed by other body organs. Andapsin forms a protective membrane over stomach ulcers. The membrane remains for several hours and is impermeable to hydrochloric acid and other irritants in the stomach. In this way, the healing process is accelerated.

Andapsin is used to heal ulcers in the stomach and duodenum , as a preventive treatment for recurrent ulcers on the duodenum and to prevent major bleeding in the stomach and duodenum .

2. Before you take Andapsin

Do not take Andapsin:

if you are allergic to sucralfate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

If you have poor kidney function, you should consult a doctor before starting treatment with Andapsin.

Lumps with indigestible contents in the stomach or intestine (bearer) have been reported after administration of sucralfate in patients with disorders of gastrointestinal motility due to surgery, drug treatment, or disease that reduces gastrointestinal motility.

Children and young people

Andapsin is not recommended for use in children below 14 years due to insufficient data.

Other medicines and Andapsin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, herbal medicines, or other natural products.

If you are taking the blood-thinning medicine warfarin, you should consult your doctor before starting concomitant Andapsine treatment as Andapsin may affect the uptake of warfarin.

Concomitant use of antacids and Andapsin should be avoided as Andapsin is activated in the acidic environment of the stomach. Antacids should be taken about 30 minutes before or after taking Andapsin.

Some medicines for infections (containing amitriptyline, ciprofloxacin , grepafloxacin, norfloxacin, ofloxacin, doxycycline, minocycline, oxytetracycline, theophylline or tetracycline ) and some antifungal medicines (containing ketoconazole ) may affect the treatment. Therefore, take these medicines either two hours before or two hours after taking Andapsin. The treating physician needs to know about other concomitant medications.

Andapsin with food and drink

Do not take Andapsin with meals. At least 1 hour between Andapsin intake and meal is recommended.

Andapsin should not be taken at the same time as citrates (which can be found in effervescent tablets and soft drinks , for example ) as it can cause you to get too much aluminum in your blood. Andapsin should be taken at least 2 hours apart from foods or beverages containing citrates. Talk to your doctor or pharmacist if you feel unsure.

Pregnancy and breastfeeding

No adverse effects on the fetus have been demonstrated.

Sucralfate does not pass into breast milk.

Driving and using machines

Andapsin has no effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Andapsin contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate

Andapsin 200 mg/ml oral solution contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).

Other ingredients

This medicine contains 4.4-8.8 mg sodium (the main ingredient in table salt/table salt) per dose (5-10 ml). A daily dose of 30 ml corresponds to 1.3% of the maximum recommended daily intake of sodium for adults.

3. How to use Andapsin

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. 

Do not take Andapsin with meals. At least 1 hour between Andapsin intake and meal is recommended.

Oral suspension: shake well before ingestion.

Dose one is determined by the doctor, who adjusts it individually for you. 
The recommended dose for adults is 2-4 grams daily divided into 2-4 doses per day.

Use for children and adolescents

Andapsin is not recommended for use in children below 14 years due to insufficient data.

If you have the impression that the effect of Andapsin is too strong or weak for you or if you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Common  ( may affect up to 1 in 10 people) :

Constipation.

Uncommon ( may affect up to 1 in 100 people ): 

Dry mouth, nausea. 

Rare ( may affect up to 1 in 1,000 people ):

Skin rash, hives. Besoarer (lumps with indigestible contents in the stomach or intestine) (see section 2).

Has been reported ( occurs in an unknown number of users ):

Allergic reactions with symptoms such as itching , hives, edema and shortness of breath.

In patients with renal impairment, small amounts of aluminum can be absorbed from the gastrointestinal tract and accumulate in the body. These patients can then suffer from bone disease, encephalitis, and anemia.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Andapsin

Keep this medicine out of the sight and reach of children.

For tablets: 
No special storage instructions.

For plastic bottles of 200 ml and sachets of 120 x 5 ml, the following applies: 
Store at a maximum of 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Other information

Content declaration

– The active substance is sucralfate. Each tablet contains 1 g of sucralfate. 1 ml of the oral suspension contains 200 mg of sucralfate.

– The other ingredients are:

In tablet: microcrystalline cellulose, carmellose calcium, polyethylene glycol, and magnesium stearate.

In oral suspension: saccharin sodium (sweetener), sodium dihydrogen phosphate dihydrate, glycerol, sodium methyl parahydroxybenzoate ( preservative E 219), sodium propyl parahydroxybenzoate ( preservative E 217), xanthan gum, flavoring (water), and caramel.

What the medicine looks like and the contents of the pack

Tablet 1 g (white, oblong, cupped with a notch, 20 mm x 9.2 mm).

Printed packaging of 60 and 120 pcs.

Oral suspension 200 mg / ml (white, caramel taste).

The plastic bottle of 200 ml, a sachet of 120 x 5 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder :

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer:

Tablets

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Suspension

Orion Corporation Orion Pharma

Volttikatu 8

FI-70700 Kuopio

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Muhammad Nadeem

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