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AUDMONAL 60 MG CAPSULES - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - AUDMONAL 60 MG CAPSULES

TFTTTI

TEVA UK LIMITED

Package leaflet: Information for the patient

Audmonal® 60mg Capsules

alverine citrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for 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 a few days.

What is in this leaflet

  • 1. What Audmonal & Audmonal Forte Capsules are and what they are used for

  • 2. What you need to know before you take Audmonal & Audmonal Forte Capsules

  • 3. How to take Audmonal & Audmonal Forte Capsules

  • 4. Possible side effects

  • 5. How to store Audmonal & Audmonal Forte Capsules

  • 6. Contents of the pack and other information

Alverine citrate belongs to a group of medicines called ‚antispasmodic‘. It works by relaxing the muscles in the intestine (gut) and uterus (womb). This helps to stop the pain you feel when these muscles tense up.

Audmonal & Audmonal Forte Capsules are used to help people who have Irritable Bowel Syndrome (IBS), some of the symptoms of IBS are

  • Abdominal pains like cramp which come and go.
  • Diarrhoea.
  • Constipation.
  • Feeling full and bloated.
  • Wanting to go to the toilet urgently.

Sometimes these symptoms are worse if you are worried or under stress.

Audmonal & Audmonal Forte Capsules can also be used for a condition of the large intestine called painful diverticular disease of the colon and to relieve period pains.

  • you are allergic to alverine citrate or any of the other ingredients of this medicine (listed in section 6).
  • your doctor has told you that you have obstruction of the gut or that your small bowel is not working properly.

Warnings and precautions

If this is the first time you have had these symptoms, consult your doctor before using any treatment.

Do not take Audmonal & Audmonal Forte Capsules if any of the following apply to you, it may not be the right treatment for you. See your doctor as soon as

possible if:

  • you are aged 40 years or over
  • you have passed blood from the bowel
  • you are feeling sick or vomiting
  • you have lost your appetite or lost weight
  • you are looking pale and feeling tired
  • you are suffering from severe constipation
  • you have a fever
  • you have recently travelled abroad
  • you are, or may be, pregnant
  • you are breast-feeding
  • you have abnormal vaginal bleeding or discharge
  • you have difficulty or pain passing urine Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.

Children

Audmonal & Audmonal Forte Capsules is not suitable for children under 12 years old.

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


It does not matter if you take Audmonal & Audmonal Forte Capsules with or without food.

Pregnancy and breast-feeding

Do not take Audmonal & Audmonal Forte Capsules during pregnancy or whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you feel dizzy while taking Audmonal and Audmonal Forte you should avoid driving or operating machinery.

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

Audmonal 60 mg Capsules:

The recommended dose is 1 or 2 capsules one to three times daily.

Audmonal Forte 120 mg Capsules:

The recommended dose is 1 capsule one to three times daily.

Swallow your capsules without chewing them with a drink.

Use in children

Audmonal & Audmonal Forte Capsules is not suitable for children under 12 years old.

It is important to stick to the dose on the label of the medicine. If you or someone else swallows several of these capsules all together, contact your doctor or nearest hospital emergency department immediately Always take any capsules left over with you and also the box, as this will allow easier identification of the capsules. Symptoms of an overdose may be low blood pressure, dizziness, increased heartbeat, dilated pupils, blurred vision, dry mouth and throat, difficulty breathing, or difficulty passing urine.

If you forget to take Audmonal & Audmonal Forte Capsules, take it as soon as you remember. If you forget for more than 4 hours, just take the next when you remember it is due. Do not take a double dose to make up for a forgotten dose.

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.

  • difficulties in breathing, shortness of breath, wheezing, swelling of your face or other parts of your body, as serious allergic reactions have been known to occur.
  • yellowing of the whites of the eyes and skin, as inflammation of the liver has been known to occur.

Tell your doctor or pharmacist if any of the following side effects occur or worsen.

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

  • a feeling of sickness or dizziness,
  • headache,
  • allergic reactions, which may include itching or skin rash,
  • increased levels of some liver enzymes (which would be detected by your doctor during a blood test).

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.



  • Forte Capsules

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original packaging.

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

  • The active substance is alverine citrate. Each capsule contains 60 mg or 120 mg of alverine citrate.
  • The other ingredients are maize starch, pregelatinized starch (Starch 1500), magnesium stearate, gelatin, black iron oxide, brilliant blue and titanium dioxide.

Sources: Original (products.mhra.gov.uk)