PARACETAMOL 500 MG TABLETS, ARDIMOL 500 MG TABLETS, ILONAMOL 500 MG TABLETS - patient leaflet, side effects, dosage

1. What Ilonamol is and what it is used for

2. What you need to know before you take Ilonamol

3. How to take Ilonamol

4. Possible side effects

5. How to store Ilonamol

6. Contents of the pack and other information

1. what ilonamol is and what it is used for

Ilonamol belongs to groups of medicines known as analgesics and antipyretics. It works by relieving pain and reducing body temperature in cases of fever.

Ilonamol Tablets are used to relieve mild to moderate pain including headache, migraine, toothache, backache, period pain and muscle and rheumatic pain.

They can also be used to relieve the symptoms of colds and flu (sore throat, fever, aches and pains), as well as relieve the pain due to mild arthritis.

2. what you need to know before you take ilonamol

Do not take this medicine if you:

• are allergic to paracetamol or any of the other ingredients in the tablets (see section 6 of this leaflet)
• are taking other paracetamol-containing products to treat pain, fever, symptoms of cold and flu, or to aid sleep

Do not take this medicine if any of the above apply to you. If you are not sure, check with your pharmacist or doctor before taking Ilonamol.

Warnings and precautions

Consult your doctor before you take this medicine if you:

• have kidney problems
• have liver problems, particularly those due to drinking too much alcohol
• suffer from mild arthritis and need to take painkillers everyday
• are under weight or malnourished
• have a severe infection as this may increase the risk of metabolic acidosis, Signs of metabolic acidosis include:

• – deep, rapid, difficult breathing

• – feeling sick(nausea), being sick (vomiting)

• – loss of appetite

Contact a doctor immediately if you get a combination of these symptoms. You may need to avoid using this product altogether or limit the amount of paracetamol that you take.

Other medicines and Ilonamol

Consult your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Paracetamol can affect the way some medicines work. Also some medicines can affect the way Paracetamol works.

In particular, tell your pharmacist or doctor if you are taking any of the following:

• medicines to treat epilepsy such as phenobarbital
• doxorubicin, used in the treatment of cancer
• aspirin, used to treat pain, inflammation or fever
• metoclopramide or domperidone, for nausea (feeling sick) and vomiting (being sick)
• cholestyramine, to reduce blood cholesterol levels
• warfarin and other coumarins, used to thin the blood and prevent clots from forming
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

If you are not sure if any of the above apply to you, talk to your pharmacist or doctor before taking Ilonamol.

Ilonamol with food and drink

Avoid alcohol whilst taking Ilonamol, as it can increase the risk of the side effects.

Pregnancy, breast-feeding and fertility

If necessary, Ilonamol Tablets can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Driving and using machines

This medicine should not affect your ability to drive or operate machines.

3. how to take ilonamol

Follow the instructions provided in this leaflet. You should check with your pharmacist or doctor if you are not sure.

Taking this medicine

• Do not exceed the recommended dose
• Do not take with other paracetamol-containing products
• If your symptoms persist for more than three days, you should consult your doctor
• Swallow the tablets with a drink of water.

The recommended dose is

Dosage:

Adults (including the elderly) and children over 16 years:

Take 1 or 2 tablets, up to 4 times a day as required. Wait at least 4 hours between doses. Do not take more than 8 tablets in any 24-hour period.

Children aged 10 – 15 years:

One tablet to be taken every 4–6 hours, when necessary, up to a maximum of 4 tablets in any 24-hour period.

Do not give more than 3 days at a time unless your doctor tells you to.

Do not take more frequently than every 4 hours.

Do not take more than the recommended dose.

Children under 10 years:

Ilonamol 500 mg Tablets is not recommended for use in children under 10 years of age. A liquid form of this medicine may be more suitable for use in children of this age.

If you take more Ilonamol than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much Ilonamol can cause delayed, serious liver damage.

If you forget to take Ilonamol

Take the next dose when needed. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

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

4. possible side effects

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

STOP TAKING this medicine and see a doctor or go to a hospital straight away if you notice any of the following side effects:

• an allergic reaction. The symptoms of which may include skin rash, itching, blistering or peeling of the skin, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, sudden wheezing or collapse.

If you get any of the following side effects, stop taking this medicine and talk to your doctor as soon as possible:

• unexplained bruising or bleeding, red-purple spots of discolouration on the skin, sore throats or infections. These may be signs of changes to your blood cells.
• skin rash or peeling, or mouth ulcers.
• breathing problems. This is more likely if you suffer from asthma and have experienced similar problems before when taking painkillers such as aspirin or ibuprofen.
• nausea, sudden weight loss, loss of appetite, abdominal discomfort, dark urine, or yellowing of the eyes and skin. These may be signs of changes to your liver.

If you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.

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.

5. how to store ilonamol

Keep out of the sight and reach of children.

Containers: Do not store above 25°C. Keep the container tightly closed. Store in the original container.

Blister packs: This medicinal product does not require any special temperature storage conditions. Store in the original package. Keep blister in the outer carton.

Do not use the tablets after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information

What Ilonamol tablets contain

The active ingredient in the tablets (the ingredient which makes this medicine work) is paracetamol.

Each tablet contains 500 mg of paracetamol.

The tablets also contain povidone, starch, magnesium stearate and stearic acid.

What Ilonamol tablets look like and contents of the pack

Marketing Authorisation Holder

Chelonia Healthcare Limited

Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited

• 84 Pembroke Road, London, W8 6NX, UK