Patient leaflet - Tenoxicam 20 mg Lyophilisate for solution for injection
1. What this medicine is and what it is used for
Tenoxicam injection contains tenoxicam, which is a non-steroidal anti-inflammatory drug (NSAID).
It helps to relieve pain and inflammation.
The injection will be given to you by a doctor or nurse into your muscles or veins.
Tenoxicam is effective for:
- reducing pain and inflammation in osteoarthritis and rheumatoid arthritis
- treating short-term injuries such as sprains and strains and other soft-tissue injuries
- when oral tablets cannot be taken.
2. Before you use
Do NOT use Tenoxicam injection if you:
- are allergic to tenoxicam, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or to any of the other ingredients in the product (see Section 6)
- have ever had a stomach or intestinal condition such as peptic ulcer, bleeding in the stomach or severe gastritis
- have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)
- have severe heart, liver or kidney problems
- are more than 6 months pregnant.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Tenoxicam injection
Before treatment with the injection, tell your doctor if you:
- are taking any other anti-inflammatory medicines (e.g. diclofenac, ibuprofen, prednisolone)
- are taking aspirin or medicines that thin the blood (e.g. warfarin, clopidogrel)
- are taking antidepressants called selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine)
- have kidney or liver problems. Your doctor will check your kidney or liver function before and during treatment
- are elderly (see Section 3)
- are trying to become pregnant (see Section on Fertility) • have stomach or digestive tract problems or if you have ever had an upset stomach after taking pain killers such as aspirin. Bleeding in the stomach or gut can occur in patients using Tenoxicam
- have a connective tissue disorder, e.g. Systemic Lupus Erythematosus (SLE)
- have problems with your vision. Medicines such as tenoxicam may affect your vision
- have asthma, or a history of asthma, as this medicine may cause breathing difficulties
- have a bleeding disorder or are having major surgery. Tenoxicam can affect the clotting of your blood. It can make you bleed more and for longer than usual
have heart problems, high blood pressure, previous stroke or think that you might be at risk of any of these conditions (e.g. if you have high blood pressure, diabetes, or high cholesterol or are a smoker). Additional monitoring will be carried out by the doctor. Medicines such as Tenoxicam may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Tenoxicam or they may affect how well Tenoxicam will work.
Tell your doctor or pharmacist if you are taking:
medicines that can increase a chance of getting ulcers or a bleed in the stomach or gut, such as:
- corticosteroids used to treat arthritis and inflammation
- medicines such as anti-platelet agents, used to thin the blood (e.g. warfarin, aspirin, clopidogrel)
- antidepressants called selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine)
- any other anti-inflammatory medicines (e.g. NSAIDs, diclofenac, celecoxib)
- medicines used for high blood pressure (e.g. atenolol, ramipril, valsartan)
- diuretics (water tablets)
- heart medicines (e.g. digoxin, sotalol, diltiazem)
- medicines which suppress the immune system (e.g. ciclosporin, tacrolimus, methotrexate)
- lithium, a medicine used to treat mood swings and some types of depression
- a medicine usually prescribed through hospitals, called mifepristone (taken within the last 12 days)
- quinolone antibiotics (antibiotics used to treat infections)
- zidovudine, a medicine used for HIV.
Blood tests
Your doctor may test your blood during treatment.
Pregnancy and breast-feeding
Pregnancy:
Tenoxicam will be passed to your unborn baby. It is not known how much it will affect your unborn baby in the first 6 months of pregnancy.
DO NOT use Tenoxicam injection if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not use Tenoxicam injection during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Tenoxicam can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
Breast-feeding:
Tenoxicam passes into breast milk and can affect the baby. You should not use
Tenoxicam injection while breast-feeding unless advised by your doctor.
Fertility:
DO NOT use Tenoxicam injection if you are trying to become pregnant as it may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Tenoxicam may cause dizziness, head-spins, blurred vision and drowsiness. If any of these occur do not drive, use machinery, or perform any tasks that may require you to be alert.
3. How to use
You will most likely receive Tenoxicam injection from a doctor or nurse. Your doctor will have decided what dose is right for you and may suggest a different dose to the usual dose shown below. You should check with your doctor or pharmacist if you are not sure.
- Your doctor or nurse will inject Tenoxicam into your muscles or veins.
Doses
Adults: the usual dose is 20 mg (one injection) for 1 or 2 days, followed by oral tablets taken at the same time each day.
The elderly:
Your doctor will decide your dose, it will usually be lower than that for other adults. While you are treated with 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: this injection is NOT suitable for children.
The normal length of treatment for:
- pain and inflammation in osteoarthritis and rheumatoid arthritis is 1 to 2 days
- acute musculoskeletal disorders, (such as strains and sprains) is 7 days but in severe cases you may be given Tenoxicam for up to 14 days.
If you use more than you should
Having too much Tenoxicam is unlikely as the injection will be given to you by a doctor or nurse. However, if you are given too much Tenoxicam, you may experience headache, nausea (feeling sick), vomiting and stomach pain. Ask your doctor or nurse if you have any concerns.
If you forget to use
If you think you have missed an injection, speak to your doctor or nurse.
If you have any further questions on the use of this product, ask your doctor or nurse, or your pharmacist.
4. Possible side effects
Like all medicines, Tenoxicam can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor or nurse immediately if you have any of the following allergic reactions:
- difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised lumps
- blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin
or any of the following reactions:
- passing blood in your stools (faeces/motions)
- passing black tarry stools
- vomiting any blood or dark particles that look like coffee grounds.
STOP using Tenoxicam and seek immediate medical attention if you have any of the following symptoms:
- indigestion or heartburn, abdominal pain (pain in your stomach) or other abnormal stomach symptoms, nausea (feeling sick), vomiting
- any unusual bruising or bleeding, for example nose-bleeds, pinpoint red spots on the skin, unusual purple bruise like rash on the skin or in the mouth
- signs of anaemia such as feeling tired, breathless, and looking pale
- fever, sore throat, mouth ulcers, repeated infections or infections that will not go away. This may be due to a low level of white blood cells
- sudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash
- fever, rash, nausea, aches and pains, passing more or less urine than usual, passing red urine or passing urine at night. This may be due to changes in your kidneys
- pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas
- yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness. This may be due to changes in your liver.
Tell your doctor if you get any of the following side effects:
- swelling of the hands and feet (around the ankles)
- a collection of symptoms including thirst, frequent urination, tiredness, and increased susceptibility to infections, such as thrush. This may be due to too much glucose in the body. Your doctor can test for this
- rapid heartbeat (palpitation)
- asthma or asthma that is worse than usual
- 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
- skin rash, redness and itchiness
- constipation or bloating
- loss of appetite
- weight gain or weight loss
- reactions to the sun. Your skin may become red, painful and swollen - do not sunbathe, use a sun bed, or expose your skin to artificial UV light
- nail changes
- hair loss
- head-spins (vertigo)
- sleepiness, inability to sleep, or abnormal dreams
- depression, nervousness
- changes to your eyesight
- feeling ill (malaise)
- ringing or buzzing in the ears (tinnitus)
- pancreatitis (inflammation of the pancreas) (very rare)
Medicines such as Tenoxicam may be associated with a small increased risk of heart attack or stroke (see Section 2 - end of 'Take special care').
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 Yellow Card Scheme at: 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
- Keep out of the reach and sight of children.
- Do not use after the expiry date which is stated on the vial label and on the carton. The expiry date refers to the last day of that month.
- Store below 30ºC.
- Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
6. Further information
What Tenoxicam injection contains
- The active ingredient is tenoxicam (20 mg).
- The other ingredients are: mannitol, ascorbic acid, disodium edetate, sodium hydroxide, tromethamine and hydrochloric acid (as a freeze-dried powder for dissolving in solvent).
What Tenoxicam injection looks like and contents of the pack
Tenoxicam is a green/yellow packed powder which is made into solution before it is given to you.
It is available in packs of 1 vial.
Marketing Authorisation Holder
Essential Generics, , 8a Crabtree Road, Egham, Surrey TW20 8RN, United Kingdom
Manufacturer
Laboratorios Alcalá Farma S.L., Carretera M-300,
km 29,920, 28802-Alcalá de Henares (Madrid),
Spain.
This leaflet was last revised in
January 2026