Aceclofenac 100mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 30306-0648 change

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Package leaflet: Information for the user Aceclofenac 100mg Film-coated Tablets

Read all of this leaflet carefully before you start using this medicine.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor, pharmacist or nurse.

- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

- The full name of this medicine is Aceclofenac 100mg Film-coated Tablets but within the leaflet it will be referred to as Aceclofenac Tablets.

In this leaflet

1. What Aceclofenac Tablets are and what they are used for

2. Before you take Aceclofenac Tablets

3. How to take Aceclofenac Tablets

4. Possible side effects

5. How to store Aceclofenac Tablets

6. Further information

1. What Aceclofenac Tablets are and what they are used for

Aceclofenac Tablets contain a medicine called aceclofenac. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Aceclofenac Tablets are used to relieve pain and inflammation in adult patients suffering from:

• arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.

• autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis).

• arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondylitis).

2. What you need to know before you take Aceclofenac Tablets Do not take Aceclofenac Tablets:

• if you are allergic (hypersensitive) to aceclofenac or any of the other ingredients of Aceclofenac Tablets

• if you are allergic (hypersensitive) to aspirin or any other NSAIDs (such as ibuprofen, naproxen or diclofenac)

• if you have taken aspirin or any other NSAIDs and experienced one of the following:

- asthma attack

- runny nose, itching and/or sneezing (irritation of the nose)

- raised red circular patchy rash on the skin which may have been itchy, stung or had a burning sensation

- severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing, wheezing, abnormal pain and vomiting

• if you have a history of, suffer from, or suspect that you have a stomach ulcer or intestinal bleeding

• if you have moderate to severe kidney disease

• if you have a heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages

• if you have or have had problems with your blood circulation (peripheral arterial disease)

• if you suffer from, or suspect that you have liver failure

• if you are pregnant (unless considered essential by your doctor)

• if you have active bleeding or a bleeding disorder.

Aceclofenac Tablets are not recommended for use in children.

Warnings and precautions

Talk to your doctor before taking Aceclofenac Tablets

• if you smoke

• if you have diabetes

• if you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides (lipids) in your blood

• if you suffer from any other form of kidney or liver disease

• if you have any of the following gastro-intestinal disorders:

- inflammatory bowel disease (ulcerative colitis)

- chronic inflammatory bowel disease (Crohn’s disease)

- have ever had bleeding from the back passage

- have ever vomited blood

• if you suffer from asthma or any other breathing problems

• if you suffer from a blood disorder known as porphyria

• if you have chicken pox or shingles, the use of this medicine should be avoided because of the risk of developing rare serious infections of the skin related to the use of aceclofenac.

• if you are recovering from major surgery

• if you are elderly (your doctor will prescribe you the lowest effective dose over the shortest duration).

Medicines such as Aceclofenac Tablets may be associated with an increased risk of heart attack ("myocardial infarction”) or stroke.

Hypersensitivity reactions and, very rarely, serious allergic reactions can occur (see section 4, Possible side effects). The risk is higher in the first month of treatment. Aceclofenac Tablets should be discontinued at the first onset of any signs of hypersensitivity.

Side effects may be reduced by using the lowest effective dose for the shortest duration necessary.

Do not exceed the recommended dose or duration of treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Please tell your doctor if you are taking:

• medicines used to treat depression or manic depression (lithium)

• medicines used to treat heart failure and irregular heart beats (cardiac glycosides)

• medicines used to treat high blood pressure (antihypertensives)

• quinolone antibiotics

• drugs used to increase the rate of urine excretion (diuretics)

• medicines that stop blood clotting (anticoagulants) such as warfarin, heparin

• methotrexate which is used to treat cancer and autoimmune disorders

• mifepristone which is used as an emergency contraceptive or to induce abortions

• any steroids (oestrogens, androgens, or glucocorticoids)

• medicines used to suppress the immune system (cyclosporin or tacrolimus)

• medicines used to treat HIV (zidovudine)

• medicines used to lower blood sugar levels (antidiabetics)

• any other NSAID drugs (aspirin, ibuprofen, naproxen).

Taking Aceclofenac Tablets with food and drink

Aceclofenac Tablets must be taken preferably with or after food.

Fertility, pregnancy and breast-feeding

You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant.

Do not take Aceclofenac Tablets if you are pregnant or think you are pregnant. The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor.

Aceclofenac Tablets should not be used if you are breast-feeding. It is not known if this medicine passes into breast milk. It is not recommended for use during breast-feeding unless considered essential by your doctor.

Consult your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you are taking Aceclofenac Tablets and you experience dizziness, drowsiness, tiredness or any visual disturbances, you must not drive or use machinery.

3. How to take Aceclofenac Tablets

Always take Aceclofenac Tablets exactly as your doctor has told you. You will be prescribed the lowest effective dose over the shortest duration to reduce side effects. You should check with your doctor or pharmacist if you are not sure.

The recommended dose in adults is 200mg (two Aceclofenac Tablets). One 100mg tablet should be taken in the morning and one in the evening.

Tablets should be swallowed whole with plenty of water and should be taken with or after food. Do not crush or chew the tablets.

Do not exceed the stated daily dose.

Elderly

If you are elderly, you are more likely to experience serious side effects (listed in section 4 ‘Possible Side Effects’).

If your doctor prescribes Aceclofenac Tablets for you, you will be given the lowest effective dose over the shortest duration.

Use in children

The use in children is not recommended

Patients with kidney problems

Your doctor will tell you what dose to take and will monitor you regularly.

Patients with liver problems

The recommended dose is one 100mg tablet a day.

If you take more Aceclofenac Tablets than you should

If you accidentally take too many Aceclofenac Tablets, contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet or the box the Aceclofenac Tablets came in, with you to the hospital so that they will know what you have taken.

If you forget to take Aceclofenac Tablets

If you miss a dose, do not worry, just take the next dose at the usual time.

Do not take a double dose to make up for a forgotten tablet dose.

If you stop taking Aceclofenac Tablets

Do not stop taking Aceclofenac Tablets unless your doctor advises you.

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

4. Possible side effects

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

Tell your doctor immediately if you have any of the following side effects:

if you experience any of the following side effects, tell your doctor IMMEDIATELY:

• Medicines such as, Aceclofenac Tablets may be associated with an increased risk of heart attack (“myocardial infarction”) or stroke.

• Severe allergic reaction (anaphylactic shock). Symptoms may develop quickly and can be life-threatening if not immediately treated and include fever, difficulty breathing, wheezing, abdominal pain, vomiting, swelling of the face and throat.

• Severe skin rashes such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. These conditions are potentially life-threatening and involve formation of large skin blisters and peeling away of the skin. The rash can also appear in the mouth, throat or eyes. Fever, headache and aching of the joints usually occur at the same time.

• Meningitis-like symptoms, including high fever, headache, vomiting, blotchy red rash, neck stiffness, sensitivity and intolerance to light. This may be due to a condition called aseptic meningitis.

• kidney failure.

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and

seek IMMEDIATE medical help:

• Pass blood in your faeces (stools/motions).

• Pass black tarry stools.

• Vomit any blood or dark particles that look like coffee grounds.

STOP TAKING the medicine and tell your doctor if you experience:

• Indigestion or heartburn.

• Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

• Extreme tiredness, breathlessness, aching of the joints, repeated infections and bruising of the skin: these signs may indicate reduced blood cell production or other blood disorders.

If any of the below side effects get serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.

Common (occur in more than 1 in 100 patients but in less than 1 in 10 patients):

• dizziness

• nausea (feeling sick)

• diarrhoea

• increased liver enzymes in the blood.

Uncommon (occur in more than 1 in 1,000 patients but in less than 1 in 100 patients):

• wind (flatulence)

• inflammation or irritation of the lining of the stomach (gastritis)

• constipation

• vomiting

• mouth ulcers

• itching

• rash

• inflammation of the skin (dermatitis)

• raised circular red itchy, stinging or burning patches on the skin (hives)

• increase in blood urea levels

• increase in blood creatinine levels.

Rare (occur in more than 1 in 10,000 patients but in less than 1 in 1,000 patients):

• low levels of iron in the blood

• hypersensitivity (allergic reaction)

• visual disturbance

• shortness of breath.

Very Rare (occur in less than 1 in 10,000 patients):

• low white blood cells levels

• low platelets levels in the blood

• abnormal breakdown of the red blood cells (anemia)

• high potassium levels in the blood

• depression

• strange dreams

• inability to sleep

• tingling, pricking or numbness of skin

• uncontrollable shaking (tremor)

• drowsiness

• headaches

• abnormal taste in the mouth

• sensation of spinning when standing still

• heart pounding or racing (palpitations)

• hot flushes

• difficulty breathing

• high pitched noise when breathing

• inflammation of the mouth

• stomach ulcer

• inflammation of the pancreas (pancreatitis)

• inflammation of the liver (hepatitis)

• yellowing of the skin (jaundice)

• spontaneous bleeding into the skin (appears as a rash)

• blisters

• water retention and swelling

• tiredness

• leg cramps

• increased blood alkaline phosphatase levels

• weight gain.

If any of the below side effects get serious, please tell your doctor or pharmacist.

Other side effects that have been reported with this type of drug (NSAIDs) are:

• hallucinations

• confusion

• blurred, partial or complete loss of vision

• painful movement of the eye

• ringing in the ears

• aggravated asthma

• ulcers

• perforation of either the stomach, large intestine or bowel wall

• blistering and peeling of the top layer of skin

• mild, itchy pink/redness of the skin

• reddening or scaling of skin

• skin irritation (eczema)

• skin reaction to sunlight

• inflammation of the kidneys

• generally feeling unwell

• aseptic meningitis

• exacerbation of colitis and Crohn’s disease

• hypertension (high blood pressure)

• cardiac failure

• bone marrow depression.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Yellow Card Scheme Website: 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 Aceclofenac Tablets

Keep out of the reach and sight of children.

Do not take Aceclofenac Tablets after the expiry date which is stated on the carton and the blister foil. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions

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. Further information What Aceclofenac Tablets contains

The active substance is aceclofenac. Each tablet contains 100mg of active substance aceclofenac.

The other ingredients are: microcrystalline- cellulose, croscarmellose sodium, copovidone (K28), talc, silica colloidal anhydrous, glicerol distearate (Type I).

The film-coating contains: Hypromellose 2910 6 mPas (E464), Microcrystalline-Cellulose, Titanium -dioxide (E171), Polyoxyl 40 (Macrogol) stearate (Type I).

What Aceclofenac Tablets looks like and contents of the pack

Aceclofenac 100mg tablets are white, round, biconvex film-coated tablets.

They are available in Alu/OPA-Al-PVC blister packs of 20, 30, 40, 50, 60, 70, 90, 100 or 180 tablets.

Not all pack sizes may be marketed

Marketing authorisation holder

Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturer

Laboratories BTT Z.I. de Krafft 67150 Erstein France

This leaflet was last revised in September 2015.

If you would like a leaflet with larger text, please contact 01271 385257.

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