LOPERAMĪDA HIDROHLORĪDS CPS 2MG N10 GRX

ATC code: A07DA03 

Active substances: Loperamidum

 Made in Latvia. 
Vendor, principal: Grindeks A/s. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

LOPERAMID-RATIOPHARM 2MG N10

Package leaflet: Information for the user

Loperamid-ratiopharm 2 mg film-coated tablets

Loperamide hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

What is in this leaflet:

1.   What Loperamid-ratiopharm 2 mg is and what it is used for
2.   What you need to know before you use Loperamid-ratiopharm 2 mg
3.   How to use Loperamid-ratiopharm 2 mg
4.   Possible side effects
5.   How to store Loperamid-ratiopharm 2 mg
6.   Contents of the pack and other information

1.   What Loperamid-ratiopharm 2 mg is and what it is used for

Loperamid-ratiopharm 2 mg is used for the symptomatic treatment of acute non-specific diarrhoea in adults and children above the age of 12.
You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

2.   What you need to know before you use Loperamid-ratiopharm 2 mg

Do not use Loperamid-ratiopharm 2 mg:
-   if you are hypersensitive to loperamide;
-   if you have an intestinal obstruction or constipation;
-   if you are a child under the age of 12;
-   if you have bloody diarrhoea with fever (e.g. dysentery);
-   if you have an inflammatory bowel disease (colitis);
-   if you have bacterial enterocolitis;
-   if you have pseudomembranous colitis (colitis caused by using antibiotics and the resulting diarrhoea);
-   if you have chronic diarrhoea;
-   if you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor before using this medicine if you suffer from any of the listed conditions.

Warnings and precautions

Talk to your doctor or pharmacist before using Loperamid-ratiopharm 2 mg.
Do not take this medicine for any other reasons than the registered indications (see section 1) and never exceed the recommended dose (see section 3). Severe cardiac problems (manifesting, for example, as a rapid or irregular heartrate) have been reported in patients who have taken excessive amounts of loperamide, the active ingredient in Loperamid-ratiopharm 2 mg.
In the following situations, Loperamid-ratiopharm 2 mg may be used only under certain conditions, with special precaution and under a doctor’s supervision. Ask your doctor for more information. The following also applies if you have experienced these conditions before.
Loperamid-ratiopharm 2 mg may not be taken without consulting your doctor if you suffer or have suffered from a liver disease because in the case of severe liver diseases, the degradation of loperamide may be slowed down and it may be expressed by overdose symptoms and result in the toxicity of the central nervous system.
AIDS patients, whose diarrhoea has been treated with loperamide, must discontinue treatment immediately when first signs of flatulence occur and talk to a doctor. The development of toxic megacolon has been reported in AIDS patients.
If there is no improvement in diarrhoea within 48 hours, discontinue treatment with loperamide and talk to a doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
No data are available on the use of this medicine during pregnancy and because the active substance of this medicine is excreted in breast milk, the use of this medicine should be avoided during pregnancy and breast-feeding. Therefore, pregnant or breast-feeding women should to talk to their doctor to receive appropriate treatment.

Driving and using machines

The possible side effects are fatigue, dizziness and drowsiness.
Therefore, when using this medicine, caution is advised when driving and using machines.

Loperamid-ratiopharm 2 mg contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Other medicines and Loperamid-ratiopharm 2 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The loperamide content in plasma increases in the case of the concomitant administration of quinidine, ritonavir, itraconazole, gemfibrozil or ketoconazole. Concomitant treatment with desmopressin increases desmopressin content in plasma. It is believed that medicines with similar pharmacological properties may increase the effects of loperamide and that medicines accelerating gastrointestinal peristalsis may decrease these effects.

Which precautions should you follow?

In the case of diarrhoea, the body may lose large amounts of fluids and electrolytes. Therefore, it is essential to preserve the fluid and electrolyte balance - drink more fluids than usual. This is especially important in children and the elderly. To restore salt content, you may purchase a special powder from a pharmacy, which contains sugar and salts.

3. How to use Loperamid-ratiopharm 2 mg

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and children above the age of 12: at the beginning, take 2 tablets (4 mg) in the case of acute diarrhoea and then 1 tablet after passing loose stools. Do not take more than 8 tablets (16 mg) a day.
If the frequency of passing stool normalises or if it is longer than 12 hours, stop taking Loperamid-ratiopharm 2 mg.
Loperamide should not be given to children aged 2-6 years without therapeutic indications and the supervision of a doctor.
Attention: in the case of diarrhoea, attention should be paid to the restoration of fluid and electrolyte content, especially in children.
If diarrhoea has not improved within 48 hours from the beginning of treatment, stop taking Loperamid-ratiopharm 2 mg and talk to a doctor.
Do not exceed the aforementioned maximum daily doses or duration of treatment, as it may cause severe constipation.
If you feel that the effect of Loperamid-ratiopharm 2 mg is too strong or too weak, talk to your doctor or pharmacist.
Elderly
No dosage adjustment is necessary for elderly patients.
Renal impairment
No dosage adjustment is necessary for patients with renal impairment.
Hepatic impairment
Inform your doctor if you have a liver disease. During treatment with Loperamid-ratiopharm 2 mg, you may need careful medical supervision, as side effects may occur more frequently in the case of hepatic impairment.

If you take more Loperamid-ratiopharm 2 mg than you should

If you have taken more of Loperamid-ratiopharm 2 mg thank you should, talk to your doctor or go to a hospital immediately. Symptoms of overdose may include rapid or irregular heartrate, changes in cardiac activity (these symptoms may have severe, life-threatening consequences), muscle stiffness, coordination disorders, drowsiness, difficulties urinating or shallow breathing.
Take the remaining tablets and pack with you, so that the doctor would know what medicine you have taken.
Children have a stronger reaction to large amounts of Loperamide 2 mg than adults. If a child overdoses on the medicine or is showing any of the symptoms listed above, talk to a doctor immediately.
If overdose symptoms occur, naloxone may be given as an antidote.

4. Possible side effects

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

Very common (> 1/10) Common (> 1/100 to < 1/10) Uncommon (> 1/1,000 to < 1/100) Rare (> 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Unknown Prevalence cannot be estimated based on available data

Immune system disorders:
Very rare: allergic reactions (anaphylactic shock and anaphylactoid reaction)
Nervous system disorders:
Common: headache Uncommon: dizziness, drowsiness
Rare: loss of consciousness, stupor (lack of response to external factors), depressed level of consciousness, muscle tension, coordination disorders
Eye disorders:
Rare: miosis (constriction of pupils)
Gastrointestinal disorders:
Common: constipation, nausea, flatulence
Uncommon: stomach ache, abdominal discomfort, dry mouth, upper abdominal pain, vomiting, dyspepsia
Rare: intestinal obstruction (incl. paralytic bowel obstruction), megacolon (incl. toxic megacolon), flatulence.
Note: if constipation occurs, discontinue treatment immediately.
Skin and subcutaneous tissue disorders:
Uncommon: rash
Rare: blistering rash (incl. Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema (swelling of the face, tongue and neck), hives, itching.
Renal and urinary disorders:
Very rare: urinary retention
General disorders and administration site reactions:
Rare: fatigue
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5.   How to store Loperamid-ratiopharm 2 mg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information

What Loperamid-ratiopharm 2 mg contains

-   The active substance is loperamide hydrochloride.
-   The other ingredients are maize starch, lactose monohydrate, microcrystalline cellulose, copovidone, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol 6000, simethicone emulsion SE4 (simethicone, silicon dioxide, sorbic acid and purified water).

What Loperamid-ratiopharm 2 mg looks like and contents of the pack

White, round, biconvex, film-coated tablets engraved with “L” on one side. The tablet is 7.1 mm in diameter and 3.1 mm in length.
The pack contains 10 tablets.

Marketing Authorisation Holder:

ratiopharm GmbH,
Graf-Arco-Str. 3,
89079 Ulm,
Germany

Manufacturer:

Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonia UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Telephone: +372 661 0801

This leaflet was last revised in August 2017