VALKET 200 RETARD - patient leaflet, side effects, dosage

VALKET 200 RETARD

(Ketoprofen 200mg Controlled-Release Capsules)

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• I f 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.

What is in this leaflet:

□ What Valket is and what it is used for Q Possible side effects

0 What you need to know before you take Valket 0 How to store Valket

0 How to take Valket 0 Contents of the pack and other information

□

What Valket is and what it is used for

Valket contains Ketoprofen and belongs to a group of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Valket works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles.

Valket is used to treat the following:

• Rheumatic disorders, such as rheumatoid arthritis and arthritis in the spine (ankylosing spondylitis)
• Degenerative joint diseases, such as osteoarthritis
• Inflammation within tendons, joints and ligaments, such as bursitis, capsulitis, synovitis, tendonitis and fibrositis
• Low back pain
• Pain in the back and leg associated with a slipped disc (sciatica)
• Acute gout
• Menstrual pain (dysmenorrhoea)

□

What you need to know before you take Valket

Do not take Valket:

• If you are allergic to ketoprofen, other NSAIDs (including aspirin, ibuprofen) or any of the other ingredients of this medicine (listed in section 6)
• If you have a history of or currently have peptic ulcers (ulcer in the stomach and/or the intestine), perforation or bleeding (including that associated with NSAID treatment)
• I f you suffer from severe heart failure, kidney or liver problems
• If you are in the last 3 months of pregnancy (see ‚Pregnancy, breast-feeding and fertility‘ section)

Warnings and precautions

Talk to your doctor before taking Valket:

• I f you have asthma combined with a chronic runny nose, blocked nose or swellings in the nose, as you have a higher risk of allergy to NSAIDs
• I f you have a history of stomach or bowel problems, including ulcerative colitis or Crohn's disease
• I f you suffer from Systemic Lupus Erythematosus (SLE) or other connective tissue disorders as there may be an increased risk of aseptic meningitis
• If you suffer from kidney or liver problems
• I f you suffer from or are at risk of heart problems as there is a small increased risk of heart attack or stroke
• I f you have a history of stomach problems as there is an increased risk of stomach bleeding, ulcers or perforation
• I f you are elderly as you may be more at risk of having side effects
• I f you are taking other medicines, such as diuretics, hydrocortisone (oral corticosteroids), warfarin (anticoagulants), citalopram (SSRIs), aspirin or other NSAIDs including COX-2 selective NSAIDs e.g. celecoxib (see „Other medicines and Valket“ section)
• I f you are trying to get pregnant as Valket may impair female fertility (see ‚Pregnancy, breastfeeding and fertility‘ section)
• I f you have an infection – please see heading „Infections“ below.

Infections

Valket may hide signs of infections such as fever and pain. It is therefore possible that Valket may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Other medicines and Valket

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

This includes herbal medicines.

Medicines which may interact with or be affected by Valket:

• Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as aspirin, ibuprofen,
• Methotrexate, used to treat psoriasis, rheumatoid arthritis and certain tumours
• Digoxin, used to treat heart failure (cardiac glycosides)
• Lithium, used to treat depression and mental illness
• Diuretics (water tablets), such as triamterene, thiazides and frusemide
• Medicines used to thin your blood, (anticoagulants) such as warfarin, heparin, clopidogrel or ticlopidine
• Sulphonamides, used to treat infections, such as trimethoprim
• Hydantoins, used to treat or prevent fits, such as phenytoin
• Medicines used to treat high blood pressure, such as atenolol (beta-blockers), medicines such as captopril (ACE inhibitors) and candesartan (angiotensin II antagonists)
• Ciclosporin or tacrolimus, used after an organ transplantation to help prevent rejection
• Mifepristone, used to terminate pregnancy. Valket should not be used for 8–12 days after mifepristone has been given
• Corticosteroids, used to treat allergies and inflammation, such as prednisolone
• Quinolone antibiotics, used to treat bacterial infections, such as ciprofloxacin
• Selective Serotonin Reuptake Inhibitors (SSRIs), used to treat depression, such as citalopram, paroxetine, fluoxetine or sertraline
• Pentoxifylline, used to help poor blood circulation in limbs
• Probenecid, used to treat gout
• Thrombolytics used to dissolve blood clots, such as streptokinase, alteplase or reteplase
• Aminoglycosides, used to treat bacterial infections, such as amikacin
• Hypoglycaemics, sulfonylureas, used to treat diabetes, such as metformin
• Zidovudine, used to treat viral infections

Taking Valket with food and drink

The capsules should be taken with or after food to minimise stomach problems.

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 for advice before taking this medicine.

Pregnancy

• Valket should not be taken during the first and second trimester (first 6 months) of pregnancy. If Valket is used, the dose should be kept as low as possible and the length of treatment as short as possible.
• Valket must not be used during the last three months of pregnancy.
• Valket should not be used during labour as the onset of labour may be delayed and the duration increased with an increased possibility of bleeding in both mother and child.

Breast-feeding

If you are breast-feeding, you should not take this medicine.

Fertility

Valket should not be taken whilst trying to become pregnant as this medicine may make it more difficult to conceive. If Valket is used, the dose should be kept as low as possible and the length of treatment as short as possible.

Driving and using machines

You should not drive, operate machinery or carry out other activities requiring full alertness if you feel confused, dizzy, tired, sick, you have a headache, eyesight problems or a have a fit while taking this medicine.

Valket contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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How to take Valket

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

• These capsules are to be taken orally
• These capsules should be swallowed whole and taken with or after food

Continued…

Till-Ver.10

• The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults:

• The usual dose is one 200mg capsule a day, taken either in the morning or at night.
• The maximum daily dose is 200mg.

Elderly:

• You should be given the lowest dose that is effective in order to avoid the risk of developing serious side effects.
• Your doctor should monitor you after starting treatment for signs of bleeding in your stomach or gut (gastrointestinal bleeding), such as black, tarry stools or if you vomit blood.

Patients with kidney or liver problems:

You should be given the lowest dose that is effective.

Use in children

This medicine should not be given to children.

If you take more Valket than you should

If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take the carton or any remaining capsules with you.

Symptoms of overdose may include: lack of energy (lethargy), feeling or being sick (nausea, vomiting), stomach pain and/or bleeding, diarrhoea, disorientation, excitement, coma, drowsiness, dizziness, ringing in the ears (tinnitus), fainting, fits (convulsions), low blood pressure (hypotension), difficulty in breathing or wheezing (bronchospasm). In cases of significant overdose, severe kidney failure or liver damage are possible.

If you forget to take your Valket

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Valket

It is important that you keep taking Valket for as long as your doctor has told you to.

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

Possible side effects

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

Seek medical advice immediately if you develop the following symptoms:

• Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)
• Blood in the stools, black, tarry stools or vomiting of any blood or dark particles that look like coffee grounds (symptoms of stomach bleeding)
• Severe blistering of the skin (toxic epidermal necrolysis), mouth, eyes and genitals (Stevens-Johnson syndrome)
• Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)
• Serious inflammation of the linings of the brain (aseptic meningitis), especially if you have an auto-immune disorder such as Systemic Lupus Erythematosus (SLE)

Common side effects (may affect up to 1 in 10 people)

• I ndigestion
• Stomach pain
• Feeling or being sick

Uncommon side effects (may affect up to 1 in 100 people)

• Headaches
• Dizziness
• Tiredness or feeling sleepy (somnolence)
• Constipation
• Diarrhoea
• Wind (flatulence)
• Pain or discomfort in the upper abdomen (gastritis)
• Rash or itching with or without a rash (pruritus)

Rare side effects (may affect up to 1 in 10,000 people)

• Pale skin, weakness or breathlessness due to a loss of blood (haemorrhagic anaemia)
• Tingling or numbness in the hands or feet (paraesthesia)
• Blurred vision
• Ringing in the ears (tinnitus)
• Coughing, wheezing, shortness of breath or tightness of the chest (asthma)
• I nflammation of the mucous lining of the mouth (stomatitis)
• Peptic ulcer (ulcer in the stomach and/or the intestine)
• Inflammation of the pancreas (pancreatitis)
• I nflammation of liver (hepatitis), abnormal liver function, liver damage, jaundice (yellowing of the skin or whites of the eyes)
• I ncrease in liver enzymes or bilirubin (detected through blood tests)
• I ncreased weight

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

• Severe reduction in number of white blood cells which makes infections more likely (agranulocytosis or neutropenia)
• Reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia)
• Tiredness, prone to infections or easily bruised due to bone marrow failure
• Severe reduction in blood cells, which can cause weakness, increase the risk of bleeding or bruising or make infections more likely (aplastic anaemia)
• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
• Mood changes
• Difficulty sleeping (insomnia)
• Fits
• Abnormal taste (dysgeusia)
• Feeling of dizziness or ‚spinning‘ (vertigo)
• Visual disturbance including optic neuritis (inflammation of the optic nerve causing blurring, blind spots, distorted vision, reduced colour vision and pain when moving the eyes. In a small number of cases blindness may occur)
• Heart failure
• High blood pressure (hypertension)
• Widening of blood vessels (vasodilatation)
• Shortness of breath or difficulty in breathing (dyspnoea), difficulty in breathing or wheezing (asthma, bronchospasm)
• Runny nose (rhinitis)
• Worsening of colitis and Crohn's disease
• Abnormal sensitivity of the skin to sunlight (photosensitivity)
• Loss of hair (alopecia)
• Skin rashes with the formation of wheals (urticaria)
• Skin rash caused by small blood vessels bleeding into the skin (purpura)
• Peeling of the skin over large areas of the body (exfoliative dermatitis)
• Kidney failure, blood in the urine, (nephritic syndrome), abnormal kidney function tests, inflammation of the kidney (interstitial nephritis)
• Tiredness, weakness or lack energy (fatigue)

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 . uk/yellowcard 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.

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How to store Valket

• Keep this medicine out of the sight and reach of children.
• Store in a dry place, below 25°C. Store in the original package in order to protect from light.
• Do not take Valket after the expiry date, which is stated on the carton/blister after „EXP“. The expiry date refers to the last day of that month.
• 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 to protect the environment.

Contents of the pack and other information

What Valket contains:

Each capsule contains 200mg of Ketoprofen in a controlled-release formulation.

The other ingredients are: macrogol, ethylcellulose, purified stearic acid, talc, polymers of methacrylic acid, acrylic acid esters and methacrylic acid esters, sucrose and corn starch.

The capsule shell contains: erythrosine (E127), titanium dioxide (E171) and gelatin.

What Valket looks like and contents of the pack:

Valket are hard gelatin size 1 capsules with an opaque pink cap and transparent body.

The capsules are either unmarked or marked ‚KZ 200 AB‘ and contain white to whitish controlled-release pellets.

Valket is available in:

Valket is available in blister packs of 28, 30, 56, 60 or 100 capsules.

Not all pack sizes may be marketed.

Product Licence Number: PL 11311/0460

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 220 Butterfield Great Marlings Luton, LU2 8DL United Kingdom

This leaflet was last revised in November 2020

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