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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)

Frequently Asked Questions

What is Audmonal 60 mg capsules used for?

Audmonal 60 mg capsules are primarily used to manage moderate to severe pain. They can be prescribed following surgery, injury, or for chronic pain conditions.

How should I take Audmonal capsules?

Take Audmonal 60 mg capsules exactly as prescribed by your doctor. Swallow the capsule whole with water, and do not crush or chew it.

Can I take Audmonal with food?

Yes, you can take Audmonal capsules with or without food. However, taking it with food may help reduce stomach upset.

What happens if I miss a dose of Audmonal?

If you miss a dose of Audmonal, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and continue your regular schedule. Do not double up on doses.

Are there any common side effects of Audmonal?

Common side effects of Audmonal may include dizziness, drowsiness, constipation, and nausea. If these persist or worsen, consult your doctor.

Is it safe to use Audmonal during pregnancy?

Audmonal is not recommended during pregnancy unless necessary. Consult your healthcare provider for advice if you are pregnant or planning to become pregnant.

Can I drink alcohol while taking Audmonal?

It's best to avoid alcohol while taking Audmonal as it can increase the risk of side effects like drowsiness and respiratory depression.

How long can I take Audmonal 60 mg capsules?

The duration of treatment with Audmonal should be determined by your doctor. It's important not to use it longer than prescribed to reduce the risk of dependence.

Can I drive after taking Audmonal capsules?

Audmonal can cause drowsiness or dizziness. It is advisable to avoid driving or operating heavy machinery until you know how this medication affects you.

What should I do if I have an allergic reaction to Audmonal?

If you experience symptoms such as rash, itching, swelling, or difficulty breathing after taking Audmonal, seek immediate medical help.

Can I take other medications with Audmonal?

Before taking any other medications with Audmonal, consult your doctor or pharmacist to avoid potential interactions.

What should I do in case of an overdose of Audmonal?

In case of an overdose, seek emergency medical assistance immediately. Symptoms may include extreme drowsiness, slow breathing, or loss of consciousness.

Will I become dependent on Audmonal?

There is a risk of dependence when using opioids like Audmonal. Always follow your doctor’s instructions and discuss any concerns about dependency with them.

Can children take Audmonal capsules?

Audmonal is generally not recommended for children under 18 years old unless specifically prescribed by a pediatrician.

Does smoking affect how well Audmonal works?

Yes, smoking can impact the effectiveness of medications like Audmonal by affecting the way they are metabolized in the body. Consult your doctor for more information.

Can my diet affect the effectiveness of Audmonal capsules?

Certain foods may interact with medications; however, a balanced diet typically does not affect how well Audmonal works unless otherwise advised by your doctor.

What precautions should I take when using Audmonal if I have liver problems?

If you have liver issues, it's crucial to inform your healthcare provider as they may need to adjust your dose or monitor you more closely while on Audmonal.

Is it safe to buy Audmonal online?

Be cautious when buying medications online; ensure that you are purchasing from a reputable pharmacy that requires a prescription from a licensed healthcare provider.

What lifestyle changes can support pain management while taking Audmonal?

Incorporating physical therapy, regular exercise within limits set by your doctor, relaxation techniques like yoga or meditation can support overall pain management alongside using Audmonal.