TENOXICAM 20 MG TABLETS - patient leaflet, side effects, dosage

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Ref: N020: SPC & PIL update in line with PRAC recommendations

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005.0 02/02/2016 8pt

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Driving or using machines

Sometimes these tablets can make you tired, feel dizzy or drowsy, have problems with your eyesight and balance, depressed or have difficulty sleeping. Talk to your doctor if any of these happen to you and do not drive or operate machinery if you experience these effects whilst using this medicine.

Other special warnings

Tenoxicam tablets contain lactose. You should not take these tablets without consulting your doctor first if you have an intolerance to lactose or some sugars.

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How to take Tenoxicam Tablets

Always take Tenoxicam Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should not be crushed or chewed, but swallowed whole with plenty of water, preferably with or after food.

Adults and children over 12:

The usual dose is one tablet taken as a single dose at the same time every day.

Elderly:

Your doctor will decide your dose, it will usually be lower than that for other adults. While you are taking Tenoxicam your doctor will want to see you to check you are on the right dose for you and look for any side effects. This is particularly important if you are elderly. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Children aged under 12 years:

This medicine is not recommended for children under 12 years of age.

The elderly and people with liver and kidney problems:

Your doctor will decide your dose, it will usually be lower than that for other adults.

If you forget to take a dose:

If you forget to take your medicine do not take a double dose to make up for a missed dose. When you remember, take the next prescribed dose and continue with the treatment. If you are concerned, consult your doctor or pharmacist.

If you take too many tablets

If you take too many Tenoxicam Tablets than you should, contact your doctor orhospital accident and emergency department immediately. Signs of an overdose include headache, feeling sick, being sick, bleeding in the stomach, drowsiness, ringing in the ears and loss of conciousness.

If you stop taking Tenoxicam Tablets

Do not stop taking your medicine without consulting your doctor as the original symptoms may return.

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

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Possible side effects

Tenoxicam Tablets are suitable for most people, but like all medicines, they can sometimes cause side effects.

Some side effects can be serious

Stop taking Tenoxicam Tablets immediately and contact your nearest accident and emergency department if you notice:

• Allergic (hypersensitive) reaction. Symptoms include skin rash, itching, painful red areas, peeling or blistering, wheezing or shortness of breath, tightness in your chest, swollen face, lips, hands or fingers or a runny nose
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee ground
• Worsening of colitis and Crohn’s disease, seen as pain, diarrhoea, vomiting and weight loss
• You bruise more easily than usual or have frequent sore throats or infections
• You experience visual disturbances
• Yellowing of your skin or the whites of your eyes
• An unexpected change in the amount of urine produced and/or it’s appearance.

Stop taking Tenoxicam Tablets and tell your doctor if you experience:

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

Other side effects

Common side effects are:

• nausea (feeling sick)
• vomiting (being sick)
• flatulence (wind)
• constipation
• pancreatitis (severe upper stomach pain, often with nausea and vomiting)
• diarrhoea
• ulcers in the mouth
• swelling due to excess fluid in the body tissue
• abnormal flushing or blistering
• stomach ulcers.

Rare side effects are:

• headaches
• palpitations
• breathing troubles
• feeling tired and sleepy
• fever
• stiff neck
• pins and needles in your hands and feet
• depression, nervousness, confusion
• hallucinations (seeing things)
• sleep problems (insomnia, nightmares)
• ringing in the ears
• vertigo
• dizziness
• swollen eyes, blurred vision, eye irritation
• changes in body weight
• loss of appetite
• problems for women in getting pregnant
• nosebleeds
• increased glucose in the blood
• kidney or liver problems
• a rash caused by exposure to sunlight
• changes in the blood (results of blood tests) such as reduced platelet count, low number of white blood cells and reduced red blood cells (anemia).

Very rare side effects are:

• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
• Pancreatitis (inflammation of the pancreas)

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

• Changes to your eyesight
• Confusion, hallucinations (possibly hearing or seeing things that are not there)
• Paraesthesia (abnormal sensation such as pins and needles, tingling or numbness especially of hands and feet), drowsiness

How to store Tenoxicam Tablets

Keep all medicines out of the reach and sight of children. Your medicines can harm them.

Do not use Tenoxicam Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 25°C.

Do not use Tenoxicam tablets if you notice any chipped tablets or any other visible signs of deterioration.

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.

0 Further information

What Tenoxicam Tablets contains

Each tablet contains 20 mg of the active ingredient tenoxicam. The other ingredients are lactose, maize starch, pregelatinised starch, magnesium stearate, talc, colloidal silicon dioxide, hypromellose, titanium dioxide (E171) and iron oxide yellow (E172).

What Tenoxicam Tablets looks like and the contents of the pack

Tenoxicam Tablets are round, yellowish film-coated tablets.

They are available as blister packs, in carton boxes of 28.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Ennogen Healthcare Ltd

Unit G2-G4 Riverside Industrial Estate Riverside Way

Dartford, DA1 5BS, UK

The manufacturer is:

Edmond Pharma,

Via del Giovi, Paderno Dugnano, Milan, Italy.

This leaflet was last approved in June 2020.

Dimensions: 146 x420 mm