Loper, 2 mg

Product description

Loper, 2 mg , tablets

Loperamidi hydrochloridum


pdf Package leaflet Loper


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 after 2 days you do not feel better or if you feel worse.

In this leaflet:
1. What Loper is and what it is used for
2. What you need to know before you use Loper
3. How to use Loper
4. Possible side effects
5. How to store Loper
6. Contents of the pack and other information

1. What Loper is and what it is used for

The active substance of Loper is loperamide hydrochloride.
Loperamide hydrochloride is an oral anti-diarrhoea medicine.
It reduces waves of muscular contraction (peristalsis) and slows down the speed at which food and stomach contents pass through the bowel. It increases the resting pressure of sphincter and reduces the instant need to have a bowel movement (urge to pass a stool).

Loper is used:
For the symptomatic treatment of acute and chronic diarrhoea. In patients with ileal stoma, Loper may be used to decrease the number and volume of stools and to increase their consistency.
Loper is for use only in adults and children aged 6 years and older.

2. What you need to know before you use Loper

Do not take Loper:
- If you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- If it is for a child under 6 years old.
- As main treatment: if you have acute dysentery, which is characterized by blood in stools and high fever; If you are having a flare-up of an inflammatory bowel condition like ulcerative colitis; if you have bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter; if you have pseudomembranous colitis associated with the use of broad-spectrum antibiotics.
- When inhibition of peristalsis is to be avoided due to the possible risk of severe complications, including intestinal obstruction, megacolon and toxic megacolon. Loper must be stopd promptly when constipation, abdominal distension or intestinal obstruction develop.

Treatment of diarrhoea with Loper is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated).

Warnings and precautions

Talk to your doctor or pharmacist before taking Loper.

In patients with diarrhoea, especially in children, dehydration and excessive loss of electrolytes may occur. Therefore, during diarrhoea more fluids should be taken than usual to supplement any deficiencies.
If there are no signs of improvement after 48 hours of treatment in acute diarrhoea, stop taking Loper and consult a doctor.
If you have AIDS and use Loper for diarrhoea, when your stomach becomes swollen stop taking the tablets immediately and contact your doctor. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

Do not take this product for anything other than its intended use (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in Loper).

Other medicines and Loper
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially any of the following:
- ritonavir;
- quinidine;
- desmopressin administered orally;
- itraconazole or ketoconazole;
- gemfibrozil.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The anticipated therapeutic benefits should be weighed against potential hazards before Loper is given during pregnancy, especially during the first trimester.

Loper should not be taken during breast-feeding.

Driving and using machines
Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal symptoms treated with loperamide. Therefore, it is advisable to use caution when driving or operating machinery.

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

3. How to use Loper

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
If after 48 hours of treatment symptoms do not disappear, or if symptoms become worse and/or new symptoms appear (such as fever), you must consult a doctor.

The recommended dose is:

Adults and children above 6 years of age

Acute diarrhoea: initially 2 tablets (4 mg) for adults and 1 tablets (2 mg) for children, then 1 tablet (2 mg) after every loose stool.
Chronic diarrhoea: initially 2 tablets (4 mg) daily for adults and 1 tablet (2 mg) daily for children; this initial dose may be modified until you have 1 to 2 normal stools daily, which usually happens by using a maintaining dose of 1 to 6 tablets (2 to 12 mg) daily.
The maximum dose in acute and chronic diarrhoea is 8 tablets (16 mg) daily for adults and children. In children, the dose must be adjusted to their body weight (3 tablets/20 kg of body weight/daily), however it must not exceed 8 tablets (16 mg) daily.
Do not use a dose exceeding the maximum recommended dose.

Use of Loper in patients with impaired kidney function and/or impaired liver function
If you have impaired liver function, this medicine must be used with care. The possible symptoms of toxic impact on the central nervous system (such as headache, dizziness, drowsiness, loss of consciousness, stupor, depressed level of consciousness, increased muscle tone, problems with coordination) must be carefully monitored.

It is not necessary to modify the dose in patients with impaired liver function.

Use of Loper in children
Loper must not be used in children under 6 years of age.
For use of Loper in children above 6 years of age, see section 3.

Use of Loper in the elderly
No dose adjustment is required for the elderly.

If you take more Loper than you should
If you take more Loper than you should, immediately contact your doctor or pharmacist.

Symptoms
Symptoms of overdose may include: stupor, uncoordinated movements, drowsiness, excessive constriction of the pupil of the eye, increased muscle tone, respiratory depression (week and slower breathing), urinary retention, and bowel obstruction (manifested by stomach ache, vomiting, flatulence and constipation). Children may be more sensitive to the toxic action of the medicine on the central nervous system than adults.

If you take more Loper than you should, immediately contact your doctor or go to the nearest hospital emergency department. The following symptoms may appear: fast heartbeat, irregular heartbeat, change in the heart's rhythm (these symptoms may have severe, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty passing urine, and shallow breathing.

In children, the reaction to taking large amounts of Loper is stronger than in adults. If a child takes too much Loper or has any of the above symptoms, contact a doctor immediately.

Management
If any of the overdose symptoms appear, a doctor may administer naloxone as an antidote. Since the time of action of loperamide is longer than that of naloxone (1 to 3 hours), it may be advisable to administer naloxone again. For this reason, the patient should be carefully monitored for a minimum of 48 hours in order to identify any possible suppression of the central nervous system function.

4. Possible side effects

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

Many side effects related to the use of loperamide are frequent symptoms of diarrhoea symptoms (stomach pain and discomfort, feeling sick, vomiting, dry mouth, feeling tired, drowsiness, dizziness, constipation, flatulence with wind). It is often difficult to differentiate these symptoms from the side effects of the medicine used.

The frequency of side effects is classified into:
Common (may affect 1 to 10 in 100 people)
Uncommon (may affect 1 to 10 in 1.000 people)
Rare (may affect 1 to 10 in 10.000 people)

The following side effects were reported in clinical trials with loperamide in acute diarrhoea:
Common: headache, constipation, flatulence, feeling sick.
Uncommon: dizziness, dry mouth, stomach pain and discomfort, vomiting, rash, upper stomach pain.
Rare: increased abdominal circumference.

The following side effects were reported in clinical trials with loperamide in chronic diarrhoea:
Common: dizziness, flatulence, constipation, feeling sick.
Uncommon: headache, dry mouth, abdominal pain and discomfort, and indigestion.

The following side effects were reported for loperamide post-marketing:
Common: headache and dizziness, constipation, feeling sick, flatulence.
Uncommon: sleeplessness, stomach pain and discomfort, dry mouth, upper stomach pain, vomiting, indigestion, rash.
Rare: immunity system disorders (hypersensitivity reaction, anaphylactic reaction, anaphylactoid reaction), nervous system disorders (problems with coordination, depressed level of consciousness, loss of consciousness, hypertonia – increased muscle tone, stupor), gastrointestinal disorders (intestinal obstruction, megacolon, burning sensation in the tongue), increased abdominal circumference, skin and subcutaneous tissue disorders (angiooedema, bullous eruption, itching, hives) and narrowing of the pupils in your eye, inability to pass urine, feeling tired.

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 to the Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB)
Al. Jerozolimskie 181C
02-222 Warszawa
Telephone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
E-mail: ndl@urpl.gov.pl

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Loper

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

This medicine requires no special storage conditions.

Do not use Loper after the expiry date shown on the pack.

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 to protect the environment.

6. Contents of the pack and other information

What Loper contains

The active substance is loperamide hydrochloride.
Each tablet contains 2 mg of loperamide hydrochloride.

The other ingredients are:
maize starch, lactose monohydrate, povidone K-30, Brilliant Blue FCF (E133), quinoline yellow (E104), magnesium stearate, talc, colloidal anhydrous silica, carboxymethyl starch sodium (type A).

What Loper looks like and content of the pack

Loper are light green coloured, capsule-shaped, biconvex tablets.

The pack contains 10 tablets in a PVC/PVDC/Aluminium blister placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna

SUN-FARM Sp. z o.o.
Człekówka 75
05-340 Kołbiel

This leaflet was last revised in: 05.2017