DICLOFENAC SODIUM 25 MG GASTRO-RESISTANT TABLETS - patient leaflet, side effects, dosage

5. How to Store Diclofenac Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Diclofenac Tablets contain: The active ingredient is diclofenac sodium 25 mg

• The other ingredients are Lactose Monohydrate, Povidone (K30), Maize starch, Sodium Starch Glycolate (Type A), Microcrystalline Cellulose (PH-102), Colloidal Anhydrous Silica, Magnesium Stearate, Purified Talc, Hypromellose, Macrogolglyce­rolHydroxyste­arate, Iron Oxide Yellow (E172), Titanium Dioxide (E171), Methacrylic Acid Ethylacrylate Copolymer (1:1) Dispersion 30% , Triethyl Citrate.

What Diclofenac Tablets look like and contents of the pack:

• The 25 mg tablets are 6.30 to 6.70 mm in diameter, round, pale yellow, enteric coated tablets, plain on both the sides.

Not all pack sizes may be marketed

This leaflet was last revised in December 2020 IPOMI

To listen to or request a copy of this leaflet in Braille, large print or audio please call,

01293 827819(UK only)

Please be ready to give the following information:

Product name

Diclofenac Sodium 25 mg Gastro-resistant Tablets

Reference number

PL 49565/0087

Marketing Authorisation Holder and Manufacturer:

Rudipharm Limited

Unit 6, Salbrook Road Industrial Estate

Salbrook Road, Redhill, Surrey, RH1 5GJ, UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diclofenac Sodium 25 mg Gastro-resistant Tablets Diclofenac Sodium

Read all of these 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, asks your doctor, or pharmacist, or nurse
• 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. See section 4
• The name of this medicine is Diclofenac Sodium 25 mg Gastro-

resistant Tablets but it will be referred to as Diclofenac Tablets throughout this leaflet.

What is in this leaflet

• 1. What Diclofenac Tablets are and what they are used for

• 2. What you need to know before you take Diclofenac Tablets

• 3. How to take Diclofenac Tablets

• 4. Possible side effects

• 5. How to store Diclofenac Tablets

• 6. Contents of the pack and other information

• 1. What Diclofenac Tablets are and what they are used for

Diclofenac tabltets contain the active ingredient Diclofenac Sodium, which is part of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are used to reduce pain and inflammation.

Diclofenac Tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including: – rheumatoid arthritis, osteoarthritis, acute gout, ankylosing spondylitis

• – backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures

• – tendonitis, tenosynovitis, bursitis.

They are also used to treat pain and inflammation associated with dental and minor surgery.

In children, Diclofenac Tablets are used to treat juvenile chronic arthritis.

In children aged 9 years and above, DiclofenacTablets can be used alone or with other medicines for short term pain relief after an operation.

2. what you need to know before you take diclofenac tablets do not take diclofenac tablets if you:

• are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclofenac Tablets (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction.
• have now, or 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 had stomach or bowel problems after you have taken other NSAIDs
• have severe heart, kidney or liver failure
• 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 bypass blockages
• have or have had problems with your blood circulation (peripheral arterial disease)
• are more than six months pregnant.
• 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 tablets, as Diclofenac tablets can sometimes worsen would healing in your gut after surgery.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Diclofenac Tablets if you:

• suffer from any stomach or bowel disorders such as ulcerative colitis or Crohn’s disease
• have a disease called porphyria (symptoms of porphyria are discolouration of the urine, serious skin disorders, anaemia, abdominal pains and severe mental disorders)
• have in the past suffered from asthma
• have serious illness with blistering of the skin, mouth, eyes and genitals or connective tissue disorders such as lupus (SLE) or any similar condition.
• have runny nose, nasal polyps, chronic lung disease or chronic lung infection
• have kidney or liver problems or if you are elderly or recovering from major surgery
• have heart problems, previous stroke or think you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker)
• have any blood or bleeding disorder
• are in first six months of your pregnancy or are breast-feeding If you notice skin rash or appearance of lesions after starting this medicine, please seek medical advice immediately.

Other special warnings

• You should take the lowest dose of Diclofenac Tablets 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 Tablets. The risk is higher 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
• Whilst you are taking these medicines your doctor may want to give you a check-up from time to time
• 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
• Because it is an anti-inflammatory medicine, Diclofenac Tablets 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 Tablets
• The 50 mg tablets are not suitable for children aged under 12.

Other medicines and Diclofenac Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Diclofenac Tablets work:

• Medicines to treat diabetes (such as Gliclazide or Tolbutamide
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets) for example spironolactone
• Lithium (used to treat some mental problems)
• Methotrexate (for some inflammatory diseases and some cancers)
• Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
• Trimethoprim (a medicine used to prevent or treat urinary tract infections)
• Quinolone antibiotics (for infections) for example ciprofloxacin, ofloxacin
• Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen
• Mifepristone (a medicine used to terminate pregnancy)
• Cardiac glycosides (for eg. digoxin), used to treat heart problems
• Medicines used to treat depression called selective serotonin reuptake inhibitors (SSRIs)
• Oral steroids (an anti-inflammatory drug)
• Medicines used to treat heart conditions or high blood pressure, for example B-blockers or ACE inhibitors
• Voriconazole (a medicine used to treat fungal infections)
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cho­lestyramine (used to lower cholesterol)

Pregnancy, breast-feeding and fertility

• Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. Do not take Diclofenac Tablets if you are in the last three months of your pregnancy as it may affect the baby’s circulation. Avoid these tablets if you are in first six months of your pregnancy or if you are breast-feeding, unless your doctor has advised you to take them
• Taking Diclofenac Tablets may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant

Driving and using machines

Diclofenac Tablets may cause dizziness, drowsiness, tiredness, and problems with your vision. Do not drive or operate machinery if you are affected

Diclofenac Tablets contains Lactose Monohydrate

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Diclofenac Tablets.

3. how to take diclofenac tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• (2)

The tablets should be swallowed whole preferably with a drink of water, before or with food. Do not crush or chew the tablets as the tablets have been coated with a substance, which allows them to pass through the stomach before dissolving. It is important that the coating is not damaged by chewing

Adults and children over 12

Recommended dose is 75 mg to 150 mg daily divided into two or three doses

Elderly and patients with kidney problems

Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly.

Paediatric population:

Children aged 1–12years

Doses vary with the age and weight of the child. The usual dose is 1 mg to 3 mg per kilogram of body weight a day. This is usually divided into two or three separate doses.

The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.

For the short term treatment of post-operative pain the following dosage should be given:

Children aged over 9 years and adolescents (weighing at least 35kg) should be given up to 2 mg/kg body weight per day in 3 divided doses, depending on the severity of the pain.

If you take more Diclofenac Tablets than you should

Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and the packaging with you so that the doctor knows what you have taken.

Symptoms of an overdose are headache, feeling sick, being sick, stomach pain, intestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, fits, ringing in the ears and fainting.

If you forget to take Diclofenac Tablets

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

Do not take more than 150 mg (six 25 mg tablets) in 24 hours.

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

4. possible side effects

Like all medicines, Diclofenac can cause side effects, although not everybody gets them.

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Some side effects can be serious

Stop taking Diclofenac Tablets and tell your doctor straight away if you notice:

• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)
• Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces
• Allergic reactions which can include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction
• a serious skin reaction such as rash, blistering or peeling of the skin (Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis)
• Yellowing of your skin or the whites of your eyes (jaundice)
• An unexpected change in the amount of urine produced and/or its appearance
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

The side effects listed below have also been reported.

Common side effects (may affect up to 1 in 10 people) :

• Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood

Rare side effects (may affect up to 1 in 1,000 people):

• Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)
• Gastritis (inflammation, irritation or swelling of the stomach lining)
• Vomiting blood
• Diarrhoea with blood in it or bleeding from the back passage
• Black, tarry faeces or stools
• Drowsiness, tiredness
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)
• Skin rash and itching
• Fluid retention, symptoms of which include swollen ankles
• Liver function disorders, including hepatitis and jaundice

Diclofenac Sodium GR Tablets - 25 mg - S/L - Eng - PIL Dimensions: 190 x 285 mm (Open Size)

Black