Voltarol 12.5 Mg Liquid Capsules
Package leaflet: Information for the patient/user
Voltarol 12.5 mg liquid capsules
Diclofenac potassium
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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
2 What you need to know before you take Voltarol 12.5 mg liquid capsules........................2
1 What are Voltarol 12.5 mg liquid capsules and what are they used for
Voltarol 12.5 mg liquid capsules contain diclofenac which belongs to a group of medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs). Voltarol 12.5 mg liquid capsules are pain relievers which also reduce inflammation (swelling) and lower body temperature.
Voltarol 12.5 mg liquid capsules provide relief from:
• muscular pain, joint pain, backache, headache, dental pain, period pain;
• symptoms of colds and flu (including aches and pains, sore throat pain). They also reduce fever.
How Voltarol 12.5 mg liquid capsules work
Voltarol 12.5 mg liquid capsules relieve the symptoms of inflammation, such as pain and swelling, by blocking the synthesis of the molecules (prostaglandins) responsible for inflammation, pain and fever. It has no effect on the causes of inflammation or fever.
If you have any questions about how Voltarol 12.5 mg liquid capsules work, ask your doctor or pharmacist.
You must contact a doctor if your symptoms worsen or do not improve within 3 days.
This medicine was prescribed for you by a doctor, follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Do not take Voltarol 12.5 mg liquid capsules if you:
• are allergic to diclofenac or to any of the other ingredients of this medicine listed in Section 6 and at the end of Section 2;
• ever had an allergic reaction to medicines used to treat pain, inflammation or fever, such as diclofenac, ibuprofen or aspirin (a substance also used to prevent blood clotting). Reactions may include: asthma, wheezing, skin rash, face swelling, runny nose. If you are not sure, ask your doctor;
• currently have or have ever had a stomach or intestinal ulcer, bleeding or perforation which may show up as a severe indigestion;
• have noticed blood in your stools or black stools or vomiting blood or your vomit looks like coffee granules (symptoms of gastrointestinal bleeding);
• suffer from severe kidney or liver disease;
• suffer from severe heart failure;
• are in the last three months of pregnancy;
Tell your doctor if any of the above apply to you because Voltarol 12.5 mg liquid capsules are not suitable for you in these circumstances.
Talk to your doctor or pharmacist before taking Voltarol 12.5 mg liquid capsules if you:
• have had stomach discomfort or heartburn after taking pain relievers or anti-inflammatory medicines in the past;
• have or have had asthma, diabetes, high cholesterol, high blood pressure, swollen feet, a stroke, liver, heart, kidney or bowel problems.
• are intolerant to some sugars
• are on a controlled potassium diet
• are a smoker
• you are at risk of being dehydrated (e.g. by sickness, diarrhea, or before or after major surgery);
• you have a bleeding disorder or other blood disorders, including a rare liver condition called hepatic porphyria.
If any of these apply, do not take Voltarol 12.5 mg liquid capsules before talking to your doctor or pharmacist.
Other precautions
• You should also be aware that medicines such as diclofenac may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more
likely with high doses and prolonged treatment. Do not exceed the recommended dose of up to 6 liquid capsules per day or the duration of treatment of up to 3 days.
• Voltarol 12.5mg liquid capsules may reduce the symptoms of an infection (e.g. headache, high temperature) and may therefore make it more difficult to detect. If you feel unwell and need to see a doctor, remember to tell that you are taking Voltarol 12.5mg liquid capsules.
• Prolonged use of any type of painkiller for headaches can make them worse. If you think that this may be the case, please contact your doctor for advice.
Other medicines and Voltarol 12.5 mg liquid capsules
It is particularly important to tell your doctor or pharmacist if you are taking any of the
following medicines:
• Lithium or selective serotonin-reuptake inhibitors (SSRIs) (medicines used to treat depression).
• Digoxin (a medicine used for heart problems).
• ACE inhibitors or beta-blockers (for high blood pressure and heart failure).
• Diuretics (to increase the amount of urine).
• Medicines used to treat diabetes, except insulin.
• Other anti-inflammatory medicines or pain killers such as aspirin, ibuprofen or naproxen (includes cyclooxygenase-2 selective inhibitors (COX2) like celecoxib).
• Corticosteroids (for relief for inflamed areas of the body).
• Medicines used to prevent blood-clotting ("blood thinners" or anticoagulants).
• Methotrexate (to treat some kinds of cancer or arthritis).
• Ciclosporin, Tacrolimus ((immunosuppressant for patients who have received organ transplants).
• Trimethoprim (a medicine used to prevent or treat urinary tract infections)
• Some medicines used against infection (quinolone antibacterials)
• Sulfinpyrazone (a medicine used to treat gout) or Voriconazole (a medicine used to treat fungal infections).
• Phenytoin (a medicine used to treat seizures).
• Colestipol and cholestyramine (medicines used to regulate cholesterol).
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Voltarol 12.5 mg liquid capsules with food and drink
Take the tablets with or after food.
Elderly
As with other pain relievers, elderly people may be more sensitive to the effects of Voltarol 12.5mg liquid capsules than other adults. Follow the instructions carefully and take the lowest number of tablets that provides relief of symptoms. It is especially important for elderly patients to report undesirable effects promptly to their doctor.
Children and adolescents (under 14 years of age)
Do not give Voltarol Pain-eze Tablets to children under 14 years of age.
Pregnancy, Breast-feeding and Fertility Pregnancy
If you are pregnant or think that you may be pregnant, tell your doctor and do not take Voltarol 12.5mg liquid capsules. It is especially important not to take Voltarol 12.5mg liquid capsules during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.
Breast-feeding
Do not take Voltarol 12.5mg liquid capsules if you are breast-feeding as it might be harmful for your infant. Tell your doctor if you are breast-feeding.
Fertility
Diclofenac belongs to a group of medicines which mayimpair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Voltarol 12.5mg liquid capsules, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.
Driving and using machines
Usually Voltarol 12.5 mg liquid capsules have no influence on the ability to drive or use machines. However, as with other pain relievers, in rare cases, patients may experience vision disorders, dizziness or drowsiness. If you notice such effects, you should not drive or use machines. Tell your doctor as soon as possible.
Important information about some of the ingredients of Voltarol 12.5 mg liquid capsules
Voltarol 12.5 mg liquid capsules contain sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor before taking this medicine.
How much Voltarol 12.5 mg liquid capsules to take
Do not take more than the recommended dose. It is important that you use the lowest dose that controls your pain and that you do not take Voltarol 12.5 mg liquid capsulesfor longer than necessary.
For adults and adolescents aged 14 years and over
Take an initial dose of 2 capsules when symptoms appear. If needed, continue with 1 or 2 capsules every 4 to 6 hours. Do not take more than 6 capsules per day.
How to take Voltarol 12.5 mg liquid capsules
• Swallow the capsules whole with a drink of water.
How long to take Voltarol 12.5 mg liquid capsules
Do not take Voltarol 12.5 mg liquid capsules for more than 3 days. If symptoms persist or worsen, tell your doctor to ensure that they are not due to a serious illness.
If you take more Voltarol 12.5 mg liquid capsules than you should
If you have taken too many Voltarol 12.5 mg liquid capsules, tell your doctor or pharmacist or go to the hospital emergency unit immediately. You may require medical attention. If possible, take the medicine with you.
If you forget to take Voltarol 12.5 mg liquid capsules>
If you miss a dose, take one as soon as you remember. If it is nearly time for your next dose, skip the missed dose and take the next capsule at the usual time. Do not take a double dose to make up for the one that you missed.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare (may affect up to 1 in every 1000 people) or very rare (may affect up to 1 in every 10,000 people) side effects can be serious.
STOP taking Voltarol 12.5mg liquid capsules IMMEDIATELY and seek medical advice if you notice:
• Severe stomach pain, blood in the stools or black stools, vomiting blood, bloody diarrhea;
• Allergic reaction including difficulty of breathing or swallowing, swelling of the face, mouth, tongue or throat, often associated with skin rash. Collapse;
• Sudden difficulty of breathing and feeling of tightness in chest with wheezing or coughing (signs of asthma);
• Sudden and oppresive chest pain (signs of heart attack), fainting, breathlessness, high blood pressure;
• Sudden and severe headache, stiff neck, difficulty to speak;
• Convulsions;
• Skin rash with blisters, peeling of the skin, purple skin lesions, blistering of the mouth or eyes skin inflammation with flaking or peeling;
• Swelling of arms, hands, legs and feet (oedema);
• Any change in the appearance or amount of urine, excess of protein in the urine, blood in urine;
• Yellowing of the skin or eyes (signs of hepatitis/liver failure), increased liver enzymes;
• Unusual bleeding or bruising, high fever or persistent sore throat, frequent infections;
• Increased sensitivity of the skin to sun.
Medicines such as diclofenac may be associated with a small increased risk of heart attack (also called "myocardial infarction") or stroke.
Other side effects
Other side effects which may occur are usually mild. Some of the effects have been reported with higher doses of diclofenac, the active substance in Voltarol 12.5mg liquid capsules, used for longer duration. If you find these are troubling you, talk to your doctor.
Some side effects are common (may affect up to 1 in every 10people)
• Pain in the gut, stomach pain, diarrhoea, nausea, vomiting, flatulence, indigestion, decreased appetite;
• Headache, dizziness;
• Skin rash;
• Vertigo.
Some side effects are rare (may affect up to 1 in every 1000 people)
• Drowsiness;
• Itchy rash
Some side effects are very rare (may affect up to 1 in every 10,000people)
• Low level of white blood cells, low level of red blood cells;
• Constipation, mouth sores, swollen, red and sore tongue, taste disorders, upper abdominal cramp;
• Itching and redness of skin, hair loss;
• Tingling or numbness of the hands or feet, trembling;
• Blurred vision, ringing in the ears, hearing impaired;
• Palpitations;
• Change in mood, difficulty sleeping, feeling confused.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard Alternatively you can call Freephone 0808 100 3352 (available from 10 am to 2pm Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5 How to store Voltarol 12.5mg liquid capsules
• Keep out of the sight and reach of children.
• Do not take Voltarol 12.5mg liquid capsules after the expiry date which is stated on the carton.
• Do not store above 30°C..
• 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 Voltarol 12.5mg liquid capsules contain
The active substance of Voltarol 12.5mg liquid capsules is diclofenac potassium. Each capsule contains 12.5 mg of diclofenac potassium.
The other ingredients are Macrogol 600, glycerol, gelatin, sorbitol (containing sorbital, sorbitan and mannitol), and quinoline yellow (E104).
What Voltarol 12.5mg liquid capsules look like and contents of the pack
Voltarol 12.5 mg liquid capsules are small, easy-to-swallow, yellow soft capsules. They are available in packs of 10, and 18 capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder
Novartis Consumer Health Camberley, GU15 3YL
Manufacturer
Novartis Consumer Health Camberley, GU15 3YL
This leaflet was last approved on:
October 2013