LOPERAMIDE HYDROCHLORIDE 2 MG CAPSULES HARD - patient leaflet, side effects, dosage

5. How to store Loperamide capsules

Package leaflet: Information for the user

Loperamide Hydrochloride 2 mg Capsules, hard

(loperamide hydrochloride)

Read all of this leaflet carefully before you start taking 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Store below 25°C.

Do not use this medicine after expiry date which is stated on the label, carton or bottle after EXP. The expiry refers to last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer required. These measures will help to protect the environment.

• 1. What Loperamide capsules is and what it is used for

• 2. What you need to know before you take Loperamide capsules

• 3. How to take Loperamide capsules

• 4. Possible side effects

• 5. How to store Loperamide capsules

• 6. Contents of the pack and other information

1. What Loperamide capsules is and what it is used for

6. Contents of the pack and other information

Loperamide capsule is used to treat two types of diarrhoea. The two types have different age limits.

What Loperamide capsules contain

The active ingredient in Loperamide Hydrochloride capsules is: loperamide hydrochloride 2 mg per capsule.

Other ingredients are: Lactose monohydrate, pregelatinized maize starch, talc and magnesium stearate.

Capsule shell: Carmoisine (E122), patent blue V (E131), quinoline yellow (E104), sunset yellow FCF (E110), titanium dioxide (E171), gelatin, iron oxide black (E172), iron oxide red (E 172), iron oxide yellow (E 172).

What Loperamide capsule looks like and contents of the pack

Loperamide Capsules are green opaque cap, grey opaque body, size ‚4‘, hard gelatin capsules, filled with white to off white powder. Approximately 14 mm in length.

They are available in blister packs of 6,8,10 and 12's capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Ltd

• 5 Marryat Close

Hounslow West

Middlesex

TW4 5DQ

UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

UK: Loperamide Hydrochloride 2 mg Capsules, hard

This leaflet was last revised in 11/2020.

Artworkcode

Short-term diarrhoea

• For adults and children aged 12 and over.
• To treat attacks that last up to 48 hours.
• If your attack lasts longer than 48 hours, talk to your doctor.

IBS diarrhoea

• For adults and young people aged 18 and over who have been diagnosed with IBS (Irritable Bowel Syndrome).
• To treat attacks that last up to 48 hours.
• If any one attack lasts continuously for longer than 48 hours, talk to your doctor.

The capsules contain loperamide hydrochloride, a substance that helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost in diarrhoea to be absorbed by the body.

2. what you need to know before you take loperamide capsules

Do not take Loperamide capsules

If you are allergic to loperamide hydrochloride, or any of other ingredients of this medicine (listed in section 6).

• a. If it is for a child aged under 12 (or under 18 for an IBS patient).

• b. If you have severe diarrhoea after taking antibiotics.

• c. If you are having a flare-up of an inflammatory bowel condition like ulcerative colitis.

• d. If you are constipated, or your stomach appears swollen (especially in children with

severe dehydration).

• e. If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature.

• f. If any of these applies to you, talk to a doctor or pharmacist and do not take Loperamide

Warnings and precautions

Talk to your doctor or pharmacist before taking Loperamide capsules.

• If you have AIDS and your stomach becomes swollen, stop taking the capsules immediately and contact your doctor.
• If you suffer from liver disease.
• If you have diarrhoea that lasts for more than 48 hours.
• If you have been told by your doctor that you have an intolerance to some sugars.
• If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal.
• if you have a history of drug abuse; loperamide is an opioid and addiction is observed with opioids as a class.

Other medicines and Loperamide capsules

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 bottle or pack to your pharmacist.

If any of these applies to you (now or in the past), talk to a doctor or pharmacist.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out. If you're affected do not drive, cycle or use machines.

Special warnings about this medicine

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 2mg capsules.

Loperamide capsules contains 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 Loperamide capsules contains carmoisine and sunset yellow FCF which may cause allergic reactions

For acute diarrhoeal

If you are taking loperamide for acute diarrhoea you should stop taking the medicine and talk to your doctor if you do not get better within 48 hours.

For acute episodes of diarrhoea associated with irritable bowel syndrome:

You should only use this medicine to treat acute episodes of diarrhoea associated with IBS if your doctor has told you that you suffer from IBS.

If you are taking loperamide for episodes of IBS you should stop taking the medicine if you do not get better within 48 hours or if the pattern of your symptoms change or repeated episodes of diarrhoea continue for more than two weeks.

If this is the first time you have had these symptoms talk to your doctor before using this medicine. This is to make sure it is suitable for you.

Extra warnings for IBS patients

Use only if your doctor has previously diagnosed IBS.

Check the following:

Do not take this medicine

If you are aged under 18.

Do not use this medicine without talking to your doctor if you:

• Are over 40 years of age
• Have passed blood in your stools or motions
• Are feeling sick or being sick
• Have lost your appetite or lost weight
• Look pale and feel tired
• Are very constipated
• Have a fever
• Have recently been travelling abroad
• Are or may be pregnant
• Have abnormal vaginal bleeding or discharge
• Have difficulty or pain when passing water

Talk to your doctor if you get new symptoms, your symptoms get worse or if they do not improve after 2 weeks of treatment.

If any of these applies to you, talk to your doctor before taking Loperamide capsules.

3. how to take loperamide capsules

Always take 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.

Check the tables below to see how much medicine to take.

• Swallow the correct number of capsules whole with a drink of water. For oral use only.
• Do not use more than the dose shown in the tables.
• The capsules are not for long-term treatment.

Short-term diarrhoea

Age	Dose
Adults and children aged 12 and over	Take two capsules to start treatment. Take one capsule after each loose bowel movement

• Do not take for attacks lasting longer than 48 hours.
• Do not take more than six capsules in a 24-hour period.
• Replace lost fluid by drinking more liquid than usual.
• Not for children aged under 12

How long to take Loperamide capsules for short-term diarrhoea

You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Loperamide capsules and talk to your doctor.

IBS diarrhoeaAgeDo­seAdults aged 18 and overTake two capsules to start treatment. Take one capsule after each loose bowel movement (or as advised by your doctor).

• You can use this medicine for up to 2 weeks for repeated attacks, but do not take for any one attack lasting longer than 48 hours.
• Do not take more than six capsules in a 24-hour period.
• Replace lost fluid by drinking more liquid than usual.
• Not for children and young people aged under 18.

Talk to your doctor and stop taking this medicine:

• If you have been using this medicine continuously for 48 hours.
• If you develop new IBS symptoms.
• If your IBS symptoms get worse.
• If your IBS symptoms have not improved after 2 weeks.

How long to take Loperamide capsules for IBS diarrhoea

You can use this medicine for up to 2 weeks for repeated attacks, but if any one attack lasts continuously for longer than 48 hours, talk to your doctor.

If you take more Loperamide capsules than you should

If you take more Loperamide capsules, 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 2mg Capsules 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 capsules

You should only take this medicine as you need it, following the dosage instructions abovecarefully.

If you forget to take a dose, take a dose after the next loose stool (bowel movement). Do not take a double dose to make up for a forgotten dose.

4. possible side effects

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

Get medical help at once

Rare: (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 get any of these, stop using the medicine and get medical help at once.

Talk to a doctor as soon as possible

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

• Itchiness or hives.
• Stomach pain or swollen stomach.

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

• Difficulties passing water.
• Severe constipation.
• Miosis (narrowing of the pupils of the eye).

If you notice any of the above, stop using the medicine and talk to a doctor.

Other effects that may occur

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

• Feeling sick, constipation or wind.
• Headache.