Loperamide Hydrochloride tablets 2 mg – patient leaflet, side effects, dosage

1. What Loperamide Hydrochloride 2 mg Tablets are and what they are used For

These tablets contain Loperamide Hydrochloride a substance which helps reduce diarrhoea (loose bowels), by slowing down the movements of your intestine to prevent loose bowels. This allows water and salts that are usually lost in diarrhoea to be absorbed by the body.

Loperamide Hydrochloride 2 mg Tablets can be used to treat two types of diarrhoea with different age limits:

The tablets can be used to relieve short term sudden attacks of diarrhoea in adults and children aged 12 years and over, to treat attacks that last up to 48 hours. If the condition does not get better within 48 hours, please speak to your doctor or pharmacist. These tablets can also be used by adults of 18 years and over who have irritable bowel syndrome (IBS) diarrhoea, which has been previously diagnosed by a doctor, to treat attacks that last up to 48 hours. This medicine can be used for up to 2 weeks for repeated attacks, but if one attack lasts continuously for longer than 48 hours, talk to your doctor.

2. What you need to know before you take Loperamide Hydrochloride 2 mg Tablets

Do not take Loperamide Hydrochloride 2 mg Tablets if you:

• Are allergic to loperamide hydrochloride, similar medicines or any of the other ingredients of this medicine (listed in section 6).
• Are a child aged under 12 years (or under 18 years for IBS).
• Have severe diarrhoea after taking antibiotics.
• Are having a flare-up of an inflammatory bowel condition like ulcerative colitis.
• Are constipated, or your stomach appears swollen (especially in children with severe dehydration).
• Have acute dysentery, the symptoms of which may include blood in your stools and a high temperature.
• Have bacterial enterocolitis (caused by invasive organisms such as Salmonella, Shigella and Campylobacter
• Have pseudomembranous colitis associated with the use of broad-spectrum antibiotics
• Are breast feeding as small amounts of Loperamide may be present in your milk

If any of these apply to you, talk to a doctor or pharmacist and do not take these tablets.

Warnings and precautions

Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.

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 these tablets.

Talk to your doctor or pharmacist before taking Loperamide Hydrochloride 2 mg Tablets if you:

• Have AIDS. If your stomach becomes swollen, stop taking the tablets immediately and contact your doctor.
• Suffer from liver disease.
• Have diarrhoea that lasts for more than 48 hours.
• Have been told by your doctor that you have an intolerance to lactose.
• Have severe diarrhoea as your body loses more fluid, sugars and salts than normal.

Consult a doctor before use if you have a history of drug abuse; loperamide is an opioid and addiction is observed with opioids as a class.

Warnings for IBS

• Only take Loperamide Hydrochloride 2 mg Tablets to treat acute episodes of diarrhoea associated with IBS if your doctor has previously diagnosed IBS.

You must check with your doctor before using this medicine if you:

• Are 40 years or over and your IBS symptoms are different this time,
• Have recently passed blood from the bowel,
• Suffer from severe constipation,
• Are feeling sick or vomiting
• Have lost your appetite or lost weight,
• Have difficulty or pain passing urine,
• Have a fever
• Have recently travelled abroad.

If any of the above applies to you, talk to your doctor before taking these tablets.

Other medicines and Loperamide Hydrochloride 2 mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including:

• Ritonavir (used to treat HIV).
• Quinidine (used to treat abnormal heart rhythms or malaria).
• Oral desmopressin (used to treat excessive urination).
• Itraconazole or Ketoconazole (used to treat fungal infections).
• Gemfibrozil (used to treat high cholesterol).

If you are unsure about any of the medicines you are taking, show the pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.

Pregnancy, fertility and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby: ask your doctor or pharmacist for advice before taking this medicine.

As with other drugs, it is not advisable to administer Loperamide during pregnancy, especially during the first trimester. If you are breast feeding: do not take this medicine. Small amounts may get into your milk. Talk to your doctor about a suitable treatment.

Driving and using machines

This medicine may make you feel tired, sleepy or dizzy. You may feel less alert, feel faint or pass out. You should not drive, cycle or use machines, until you are sure you are not affected. Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take 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 48 hours (short term diarrhoea) or 14 days (irritable bowel syndrome)

  LOPL/3 Loperamide Hydrochloride 2 mg Tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Loperamide Hydrochloride 2 mg Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for short term diarrhoea is: Adults and children over 12 years, two tablets to start treatment, then one tablet after each loose bowel movement. Swallow each tablet with water.

Do not take more than 6 tablets in any 24 hours.

Do not take these tablets for attacks lasting longer than 48 hours. Replace lost fluid by drinking more liquid than usual. The recommended dose for diarrhoea associated with IBS, which has been diagnosed by a doctor is:

Adults (aged 18 years and over) two tablets to start treatment, then take one tablet after each loose bowel movement (or as advised by your doctor). Swallow each tablet with water. Do not take more than 6 tablets in any 24 hours.

You can take these tablets for up to 14 days for repeated attacks, but do not take for any one attack lasting longer than 48 hours. Replace lost fluid by drinking more liquid than usual. Use in children and adolescents

Do not use in children under 12 years old with short term diarrhoea.

Do not use in children and adolescents under 18 years old for diarrhoea associated with IBS.

Talk to your doctor and stop taking this medicine if:

• you have been using this medicine continuously for 48 hours.
• you develop new IBS symptoms.
• your IBS symptoms get worse.
• your IBS symptoms have not improved after 2 weeks. If you take more Loperamide Hydrochloride 2 mg Tablets than you should

If you have taken too many tablets, immediately contact a doctor or hospital for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing. Children react more strongly to large amounts of Loperamide Hydrochloride than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately. If you forget to take Loperamide Hydrochloride 2 mg Tablets

Do not take a double dose to make up for a forgotten dose. You should take a dose after the next loose stool. Only take this medicine as you need it, following the dosage instructions above carefully.

If you stop taking Loperamide Hydrochloride 2 mg Tablets

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

4. Possible side effects

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

Rare serious reactions: may affect up to 1 in 1,000 people

• Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of face and throat.
• Skin rashes, which may be severe and include blistering or peeling skin
• Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert), uncoordinated movements.

If you experience any of the above symptoms after taking this medicine, stop using the medicine and go to the nearest hospital IMMEDIATELY.

Uncommon side effects: may affect up to 1 in 100 people

• Itchiness or hives,
• Burning or prickling sensation of the tongue,
• Swollen stomach or stomach ache.

Rare side effects: may affect up to 1 in 1,000 people

• Difficulties passing water,
• Severe constipation,
• Muscle stiffness,
• Miosis (narrowing of the pupils of the eyes).

If you experience any of the above, stop using this medicine and talk to a doctor as soon as possible.

Other effects that may occur

Common: may affect up to 1 in 10 people

• Feeling sick, constipation or wind,
• Headache.

Uncommon: may affect up to 1 in 100 people

• Dizziness or drowsiness,
• Vomiting, indigestion,
• Dry mouth.

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

• Tiredness
• Tense or tight muscles

Not known (frequency cannot be estimated from the available data)

Upper abdominal pain, abdominal pain that radiates to back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis). If you get any of these, stop using the medicine and get medical help at once.

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Loperamide Hydrochloride 2 mg Tablets

Keep this medicine out of the sight and reach of children. Store below 25˚C. Store in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. 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 Loperamide Hydrochloride 2 mg Tablets contain

Each tablet contains 2 mg Loperamide hydrochloride The other ingredients are: Ludipress (consisting of lactose monohydrate 94%, polyvinylpyrrolidone 6%, 50:50 mixture of kollidone 30 and kollidon CL) and magnesium stearate.

What Loperamide Hydrochloride 2 mg Tablets looks like and contents of the pack

Loperamide Hydrochloride 2 mg tablets are white, round, biconvex tablets marked "a L" on one side and plain on reverse.

Available in packs of 12 tablets.

Marketing Authorisation Holder and Manufacturer

Aspar Pharmaceuticals Ltd,

Albany House, Acrewood way,

St Albans, AL4 0JY,

United Kingdom

PL 08977/0044

This leaflet was last revised in November 2024 _LOPL/3