Product Details

Before you take Diclofenac Tablets DO NOT take Diclofenac Tablets.

Talk to your doctor if you: • are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclofenac Tablets. (These are listed at the end of the leaflet). Signs of an allergic reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain,runny nose, skin rash or any other allergic type reaction. uk-pl-clean0361 Pg. 1 Sandoz Ltd Page 2 Diclofenac 25 Tablets PL 04416/0361 PIL.0361.006.0d 06/09/2019 V021 : SPC and PIL update in line with PSUSA outcome SL • have ever had a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces). • have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages. • have or have had problems with your blood circulation (peripheral arterial disease). • have had stomach or bowel problems after you have taken other NSAIDs. • have severe heart, kidney or liver failure. • are more than six months pregnant. • are having an acute attack of porphyria. Talk to your doctor before taking Diclofenac Tablets if any of the following apply to you: • any stomach or bowel disorders including ulcerative colitis or Crohn’s disease. • kidney or liver problems or you are elderly. • a condition called porphyria. • any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets. • asthma, allergic rhinitis (including hay fever), nasal polyps (swelling or lumps in your nose), problems with your lungs including a long-term chest infection or had an allergic reaction to anything. • angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides. • heart problems or have had a stroke or you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or you are a smoker). • you smoke. • you have diabetes. • Lupus (SLE) or any similar condition. • an inherited intolerance to some sugars such as lactose. (Diclofenac Tablets contain a small amount of lactose). Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before receiving/taking/using Diclofenac, as Diclofenac can sometimes worsen wound healing in your gut after surgery. If you can say ‘yes’ to any of the above, ask your doctor or pharmacist for advice before taking this medicine. It may not be suitable for you or you may need to take special care when taking it. Taking other medicines Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself, including herbal remedies, as well as medicines on prescription from your doctor. uk-pl-clean0361 Pg. 2 Sandoz Ltd Page 3 Diclofenac 25 Tablets PL 04416/0361 PIL.0361.006.0d 06/09/2019 V021 : SPC and PIL update in line with PSUSA outcome SL There may be problems if you take Diclofenac Tablets with certain other medicines. Tell your doctor or pharmacist if you are taking any of the following: • Medicines to treat diabetes. • Medicines that affect blood clotting (eg anticoagulants to ‘thin’ your blood such as warfarin or anti-platelet agents such as aspirin). • Diuretics (water tablets). • Lithium (used to treat some mental problems). • Methotrexate (for some inflammatory diseases and some cancers). • Ciclosporin and tacrolimus (for some inflammatory diseases and after transplants). • Quinolone antibiotics (for infections). • Any other NSAID or COX-2 inhibitor, for example aspirin, ibuprofen or celecoxib). • Mifepristone (used to terminate pregnancy). • Cardiac glycosides (for example digoxin), used to treat heart problems. • Medicines known as SSRIs, and an SNRI, venlafaxine, used to treat depression. • Corticosteroids (anti-inflammatory drugs). • Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitors. • Ritonavir and zidovudine (used to treat HIV AIDS). • Baclofen, a muscle relaxant often used in MS. • Drospirenone (used in an oral contraceptive pill). • Ketorolac (used to treat post-operative pain). • Penicillamine, a treatment for rheumatoid arthritis. • Erlotinib (for cancer). • Iloprost, a treatment for pulmonary hypertension (high blood pressure in the artery carrying blood from the heart to the lungs). • Pentoxifylline (used to treat circulation disorders). • Sibutramine (for obesity). · Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections). • Phenytoin, a treatment for epilepsy. Pregnancy and lactation You should not take Diclofenac Tablets during the last 3 months of pregnancy as it may affect the baby’s circulation. If you are in the first 6 months of pregnancy talk to your doctor before taking this medicine as Diclofenac Tablets should only be taken if the benefit is likely to outweigh the risks. Taking Diclofenac Tablets may make it more difficult for you to get pregnant. You should talk to your doctor if you are planning to become pregnant or if you have problems getting pregnant. If you are breast-feeding, avoid taking this medicine because very small amounts of diclofenac sodium have been found in breast milk. Driving or using machinery uk-pl-clean0361 Pg. 3 Sandoz Ltd Page 4 Diclofenac 25 Tablets PL 04416/0361 PIL.0361.006.0d 06/09/2019 V021 : SPC and PIL update in line with PSUSA outcome SL Very occasionally people have reported that Diclofenac Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery. Other special warnings • You should take the lowest dose of Diclofenac for the shortest possible time, particularly if you are underweight or elderly. • There is a small increased risk of heart attack or stroke when you are taking any medicine like Diclofenac. The risk is greater if you are taking high doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for. Do not exceed the recommended dose or duration of treatment. • Your doctor may want to give you an occasional check-up whilst you are taking this medicine. • If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms. • Diclofenac may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac. • The 50 mg tablets are not suitable for children aged under 12. • The 25 mg tablets contain sunset yellow FCF (E110), which may cause allergic reactions in some people.