25 mg Tablets
What Voltaren T is and what it is used for
Voltaren T suppresses inflammation, relieves pain, and lowers fever. Voltaren T belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory/anti-rheumatic drugs).
The Voltaren T can be used for temporary mild to moderate pain conditions, e.g. headache, toothache, muscle and joint pain, back problems, menstrual pains and in case of fever in cold diseases.
Please note that the doctor may have prescribed the medicine for a different area of use and/or with a different dosage than stated in the package insert. Always follow the doctor’s prescription and instructions on the label on the medicine package.
What you need to know before using Voltaren T
Do not use Voltaren T
• if you are allergic to diclofenac , aspirin, ibuprofen or any other NSAID preparation, or to any ingredient in Voltaren T (Indicated in section 6). Signs of a hypersensitivity reaction may be swelling of the face and mouth ( angioedema ), difficulty breathing, chest pain, runny nose, skin rash or any other type of allergic reaction .
• if you have previously had allergic reactions such as asthma, runny nose, or skin rash when you have taken painkillers containing acetylsalicylic acid or other medicines for pain/inflammation in the NSAID group,
• if you have severe liver disease
• if you have an increased tendency to bleed
• if you have porphyria (metabolic disease)
• if you have or have had recurrent stomach ulcers or duodenal ulcers
• if you have previously had stomach ulcers or duodenal ulcers during troftment with diclofenac or similar preparations
• if you have a known heart disease and/or disease in the blood vessels of the brain,e.g. heart attack, s,troke , “mini-stroke” ( transient ismic attack, TIA ). You may also have had narrowings in the blood vessels to the heart or brain, or have had surgery for such narrowings by clearing vessels or via a bypass operation
• if you have or ha,ve had problems with blood circulation peripheral vascular disease)
• if you have severe kidney disease
• during the last 3 months of pregnancy
Inform your doctor if you have recently had or are going to have surgery on your stomach or intestinal tract before taking Voltaren T 25 mg because Voltaren T 25 mg can sometimes impair wound healing in the intestines after surgery.
Warnings and precautions
| Higher doses than those recommended may entail serious risks. Never use several different painkillers at the same time without consulting a doctor or pharmacist |
Side effects can be minimized by treating with the lowest effective dose for the shortest possible time. In general, a higher dose than recommended can entail risks. This also means that the combination of several NSAID preparations at the same dose should be avoided.
If you have or have had the following diseases, you should consult a doctor before treatment with
The Voltaren T is started:
– diabetes
-angina, blood clots, high blood pressure
– gastric ulcer or duodenal ulcer
– inflammatory bowel disease ( ulcerative colitis, Crohn’s disease )
-liver disease
– heart or kidney disease
– inflammation of the mucous membranes of the nasal cavities, asthma, COPD ( chronic obstructive pulmonary disease ), chronic infection of the respiratory tract, or allergic reactions such as hives or angioedema (periodically occurring local swellings)
– SLE (connective tissue disease)
-blood diseases and diseases with an increased tendency to bleed
Before receiving diclofenac, tell your doctor
– if you smoke
– if you have high cholesterol or triglyceride values (blood fats)
Elderly people should be observant of the increased risk of side effects that exist in older age.
NSAIDs including Voltaren T can rarely cause stomach ulcers which can occur at any time during treatment with or without warning symptoms. Patients who experience problems from the gastrointestinal tract, especially elderly patients, should contact a doctor in case of abdominal symptoms.
Like other NSAIDs, Voltaren T can mask signs or symptoms of infection.
In case of chickenpox, this medicine should not be used.
Use of Voltaren T (as well as all drugs that inhibit cyclooxygenase/prostaglandin synthesis) may make it more difficult to get pregnant. Consult a doctor if you are planning pregnancy or if you have problems conceiving. The effect is temporary, i.e. it stops when you stop using these types of drugs.
Medicines such as Voltaren T can lead to a slightly increased risk of heart attack or stroke . Such an increase in risk is more likely when using high doses and during long-term treatment. Do not exceed the recommended dose or treatment period of 5 days for the pain and 3 days for fever.
You should pay attention to signs and symptoms such as chest pain, shortness of brwith, weakness, slurred speech that may come without warning. If you experience these symptoms, contact your doctor immediately.
If pain relievers for headaches are used for a longer periodtime, the headache may worsen. Contact your doctor if The use think this applies to you.
Use of other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might be taking any other medicines.
Voltaren a T can affect or be affected by certain medicines that contain the following active substances:
-anticoagulants (e.g. warfarin, ticlopidine, acetylsalicylic acid, heparin ),
– medicines for the treatment of diabetes, ith the exception of insulin,
-lithium or selective serotonin reuptake inhibitors ( SSRI ) (used in certain types of depression)
– digoxin (used for heart problems)
-tacrolimus (used in transplants and eczema )
-ciclosporin (used in transplants, in severe psoriasis and rheumatism)
-certaiand n medicines against high blood pressure (so-called beta-receptor blocking agents, angiotensin II antagonists, and ACE inhibitors )
– diuretics (water-reducing agents that are also used against high blood pressure )
-quinolone antibiotics (used for urinary tract infections)
– corticosteroids (used to treat inflammatory diseases)
-colestipol or cholestyrami,ne (used for high blood lipids)
-rifampicin ( antibiotic for tuberculosis )
-carbamazepine (used in epilepsy )
– St. John’s wort
– methotrexate (used in psoriasis, rheumatism, and some forms of cancer)
-sulfinpyrazone (used in gout )
-voriconazole or fluconazole (used for fungal infections)
– phenytoin (used in epilepsy )
– amiodarone (used for heart rhythm disturbances)
-trimethoprim (used to prevent or treat urinary tract infections)
Concomitant use of other NSAIDs should be avoided as the risk of side effects increases.
Children and young people
Voltaren T 25 mg should not be given to children and adolescents under the age of 18.
Pregnancy, breastfeeding, and fertility
Ingestion of Voltaren T can inhibit fertility in women and should be avoided by women who are trying to conceive or are pregnant. Treatment during any part of the pregnancy must only take place after a doctor’s prescription.
Voltaren T passes into breast milk. To avoid effects on the child, Voltaren T should not be used during breastfeeding.
Driving ability and use of machinery
Voltaren T can cause side effects such as visual disturbances, dizziness or drowsiness in some people. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Voltaren T contains excipients
The tablets contain sucrose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to use Voltaren T
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.
Temporary mild to moderate pain conditions and fever in cold illnesses
A,dults (over 18 years): 1 tablet (25 mg) every 4 to 6 hours as needed. Do not take more than 3 tablets (75 mg) per day. Do not exceed the indicated dose. Contact a doctor if symptoms worsen or do not improve within 3 days for fever and 5 days for pain.
If you feel that the effect of Voltaren T i too strong or too weak, contact your doctor or pharmacist.
The tablets are swallowed together with the liquid. The tablets should not be split or chewed.
If you have used too much Voltaren T
If you have ingested too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. Some side effects can be serious.
Stop taking Voltaren T and tell a doctor immediately if you notice the following symptoms:
- Infection with fever with greatly worsened general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or vomiting. Voltaren T can affect the white blood cells so that the defense against infection deteriorates (very rare). A blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you inform the doctor about your medication when contacting the doctor.
- Symptoms such as swelling of a. face, tongue and/or pharynx and/or difficulty swallowing or hives occurring together with difficulty breathing ( angioedema ) occurs (very rare).
- Skin rash or damage to the mucous membranes. Serious skin reactions (Steven Johnson’s syndrome ( mucosa and skin inflammation with blisers and high fever) and Lyell’s syndrome (like Steven-Johnson’s syndrome but also with sudden skin peeling)) with the use of NSAIDs have been reported (very rare).
- Palpitations or sudden chest pain (signsthe of a heart attack). If you become short of breath, have difficulty breathing when you lie down or if your feet or legs swell (signs of heart failure ) (uncommon).
- Mild cramping and tenderness in the stomach, which begins shortly after starting treatment with Voltaren T and is followed by rectal bleedinYou must informithin 24 hours of the onset of stomach pain (reported, occurring in an unknown number of users).
- Chest pain,n, which may be a sign of a potentially serious allergic reaction called Kuoni’s syndrome (Not known)
The followinoccur effects have also been reported when using Voltaren T
Common (may affect up to 1 in 100 users): Stomach pain, nausea, vomiting, diarrhea, indigestion, decreased appetite, increased flatulence, headache, dizziness, vertigo, skin rash, elevated liver values.
Uncommon (may affect up to 1 in 100 people): spasm of the trachea.
Rare (may affect up to 1 in 1,000 users): Fatigue, swelling of the body due to fluid retention, hypersensitivity reaction ( hives, allergic shock reaction with drop in blood pressure), gastritis, stomach ulcer, stomach bleeding (vomiting blood, blood in the stool, bloody diarrhea), impotence (uncertain relationship), liver function disorders (inflammation of the liver, jaundice), asthma (including shortness of breath).
Very rare (may affect up to 1 in 10,000 users including isolated reports): Effects on vision (blurred vision, double vision) and hearing (impaired hearing, tinnitus), difficulty falling asleep, nightmares, irritability, anxiety, depression, memory disturbances, confusion, distorted perception of reality ) _ _ _ _ _ _ _ _ _ _ _ _, eczema, itching, skin redness, hair loss, photosensitivity reactions, effects on the kidneys (e.g. reduced or stopped urine production and blood in the urine), liver failure, meningitis or pneumonia without a bacterial cause, stroke, intestinal problems (e.g. constipation, inflammation of the intestine with bleeding), deterioration of Crohn’s disease and ulcerative colitis, inflammation of the tongue, mouth or esophagus, inflammation of the pancreas.
For NSAIDs , serious skin and soft tissue infections occur in rare cases in connection with chickenpox.
Medicines such as diclofenac can lead to a slightly increased risk of heart attack or stroke, the risk increases with higher doses and long-term treatment.
How the Voltaren T should be stored
Store out of sight and reach of children.
Use before the expiry date stated on the carton and printed packaging after Ex.date. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the harmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
– The active ingredient is diclofenac potassium. 1 tablet contains 25 mg of diclofenac potassium.
– Other ingredients are calcium phosphate, anhydrous colloidal silicon dioxide, magnesium stearate, corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, macrogol 8000, sucrose, talc, titanium dioxide (dye E 171), red iron oxide (dye E 172).
Appearance and package sizes of the medicine
The tablet is 7 mm, and bright red.
Pressed packaging of 10 and 20 tablets.
Not all pack sizes may be marketed.
GlaxoSmithKline Consumer Healthcare A/S
Nykær 68
2605 Brøndby
Denmark
phone: 020-100579