1. what diclo-sr 75 is and what it is used for

Diclo-SR 75 contains the active substance diclofenac sodium. Diclofenac sodium is one of the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

Diclo-SR 75 may be used for the relief of pain and swelling in a wide range of conditions including arthritis, musculoskeletal disorders or gout and pain caused by injury or minor surgery.

Diclo-SR 75 is specially formulated to release the active ingredient slowly, over a long period of time.

2. what you need to know before you take diclo-sr 75 do not take diclo-sr 75 if:

• You are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6)
• You think you may be allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclo-SR 75. (These are listed at the end of the leaflet.) 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
• You 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)
• You have had stomach or bowel problems after you have taken other NSAIDs
• You have severe heart, kidney or liver failure
• You 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
• You have or have had problems with your blood circulation (peripheral arterial disease)
• You are in the last trimester of pregnancy.

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

• Pass blood in your faeces (stools/motions)
• Pass tarry black stools
• Vomit any blood or dark particles that look like coffee grounds
• STOP TAKING the medicine and tell your doctor if you experience: indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Warnings and precautions

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 Diclo-SR 75, as Diclo-SR 75 can sometimes worsen wound healing in your gut after surgery. Talk to your doctor, pharmacist or nurse before taking Diclo-SR 75 if you:

• Suffer from asthma, or any other breathing condition
• Are an elderly person
• Have System Lupus Erythematous (SLE or ‘Lupus’) or other connective tissue disorders
• Suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s disease
• Suffer from heart problems
• Suffer from liver or kidney problems
• Have porphyria (enzyme deficiency affecting the chemicals responsible for blood production in the body)
• Suffer from any blood or bleeding disorders
• Are a female attempting to conceive.

Make sure your doctor knows, before you are given diclofenac:

• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

Medicines such as Diclo-SR 75 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 or duration of treatment.

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

If you go into hospital to see a doctor or you have a dental appointment, tell them that you are taking Diclo-SR 75.

If you suffer from any blood or bleeding disorder your doctor may ask you to have regular check ups while taking these tablets.

Other medicines and Diclo-SR 75

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

Especially:

• Aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs for pain relief (e.g naproxen, diclofenac)
• Anticoagulants such as warfarin to prevent blood clots
• Antihypertensives to treat high blood pressure
• Methotrexate and ciclosporin used to treat rheumatoid arthritis and psoriasis
• Corticosteroids used as anti-inflammatory treatments
• Mifepristone (now or at any time in last 12 days)
• Lithium used in the treatment of depression
• Diuretics (water tablets) used to treat blood pressure and water retention
• Digoxin and other medicines used to treat heart problems
• Phenytoin used to treat epilepsy
• Sulphonylureas such as gliclazide or glibenclamide used to treat diabetes
• SSRIs (Selective serotonin reuptake inhibitors) used to treat depression such as fluoxetine and paroxetine
• Anti-platelet agents used to prevent blood clots from forming that can lead to heart attack or stroke e.g aspirin, clopidogrel, ticlopidine, dipyridamole
• Tacrolimus used for immunosuppression
• Zidovudine used in the treatment of AIDS and HIV infection
• Trimethoprim used to prevent or treat urinary tract infections
• Colestipol/cho­lestyramine used to lower cholesterol
• Voriconazole used to treat fungal infections
• Quinolone antibiotics used to treat infections.

Diclo-SR 75 with food and drink

Always take the tablets with plenty of water, preferably with a meal. Try to take them at the same times every day.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Diclofenac does pass into the mother’s milk; therefore breast-feeding should be avoided if taking Diclo-SR 75.

Diclo-SR 75 should not be taken in the last 3 months of pregnancy.

Diclo-SR 75 may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

Undesirable effects such as visual disturbances, dizziness, vertigo, drowsiness and tiredness are possible after taking medicines of this type. If you are affected do not drive or operate machinery.

Diclo-SR 75 contains ethanol and lactose monohydrate This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

This medicine also contains lactose monohydrate, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. how to take diclo-sr 75

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The lowest effective dose should be used for the shortest possible time.

Use in adults and the elderly:

The recommended dose is one tablet once or twice daily, taken whole with plenty of water preferably with food or after food.

Elderly patients are more likely to experience side effects. Therefore treatment should be started on the lowest possible dose for the shortest possible duration. Your doctor should monitor your condition regularly.

180 × 280 mm

ARTWORK DETAIL LABEL

Product	DICLO-SR 75
Buyer/Country	SPUK	Component	Pack Insert
Dimension	180 × 280mm			Pack	–
New Item Code	1041245	Old Item Code	1039998
Colour Shades	BLACK			No. of Colours	1

Change Control No.	Record Number: 264154 Artwork Version 6.0
Design/Style	Front & Back Printing. To be supplied in unfolded size.
Substrate	60 GSM Paper.
Special Instructions	Printing clarity to be clear & sharp.
Autocartonator Requirements	Pack insert supply should be as per auto-cartonator. Refer auto-cartonator drawing for instructions.
Caution to the printer: Before processing, please ensure that the ARTWORK received for printing Is exactly in line with APPROVED ARTWORK provided to you. In case of any FONTS/DESIGN are Mis-matching with the APPROVED ARTWORK, please inform PDC for further action. DO NOT MAKE ANY CHANGE TO THE ARTWORK WITHOUT WRITTEN INSTRUCTIONS FROM PDC.

Use in children:

Diclo-SR 75 is not recommended for use in children.

If you take more Diclo-SR 75 than you should

If you accidently take too many Diclo-SR 75 tablets, tell your doctor at once. If you can’t do this, go to the nearest casualty department. Take along any tablets that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take Diclo-SR 75

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

If you stop taking Diclo-SR 75

Continue to take the tablets for as long as your doctor tells you to. Talk to your doctor if you have any concerns.

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

4. possible side effects

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

Serious side effects:

If you suffer from any of the following side effects, STOP TAKING the tablets and seek immediate medical help:

• – Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

• – Pass blood in your faeces (stools/motions)

• – Pass black tarry stools

• – Vomit any blood or dark particles that look like coffee grounds

• – Indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Medicines such as Diclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If you experience any of the following stop taking the tablets and contact your doctor immediately:

• All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eye lids, face or lips, rash, reddening of the skin or itching (especially affecting your whole body)
• Severe painful skin disorder with blisters and peeling skin. You may also have flu-like symptoms such as fever or sore throat (Stevens-Johnson Syndrome)
• Jaundice with symptoms of yellowing of eyes and skin
• Diarrhoea (stop taking Diclo-SR 75 and do not take it again)
• Blood disorders; you may have a persistent sore throat or high temperature, anaemia (feeling tired after exercising, giddiness, looking pale)
• Respiratory problems: including inflammation of the lungs which causes breathlessness, cough and raised temperature and aggravated asthma
• An unexpected change in the amount of urine produced and/or its appearance.

The side effects listed below have also been reported.

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

• Nausea, vomiting, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.

Uncommon (may affect up to 1 in 100 people):

• Palpitations (fast or irregular heart beat)
• Chest pain
• Heart disorders, including congestive heart failure.

These symptoms are generally associated in those on longterm treatment with a high dose (150mg per day).

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

• Gastritis (inflammation, irritation or swelling of the stomach lining)
• Drowsiness, tiredness
• Fluid retention, symptoms of which include swollen ankles Liver function disorders, including hepatitis
• Raised, itchy rash (Urticaria).

5. how to store diclo-sr 75

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not use this medicine if you notice visible signs of deterioration. 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 informationwhat diclo-sr 75 containsthe active substance is diclofenac sodium. each tablet contains 75mg diclofenac sodium.

The other ingredients are:

Ethanol (see section 2)

Lactose Monohydrate (see section 2) Magnesium Stearate Methylhydroxpro­pylcellulose Microcrystalline cellulose Iron oxide red (E172) Povidone

Talc

What Diclo-SR 75 looks like and contents of the pack

Description: Light-pink, round convex tablets

Contents of pack: Prolonged release tablets; Packs of 28 and 56 tablets.

PP-container with PE lids Pack sizes: 28, 56, 100 tablets HDPE-container with PE lids: Pack sizes 28, 56, 100 tablets Aluminium foil/PVDc/PVC blister strips: Pack sizes 10, 20, 28, 30, 50, 56, 60, 90 and 100 tablets

Blister strips consisting of push through aluminium foil with a form packing bottom strip of aluminium foil: Pack sizes: 10, 20, 28, 30, 50, 56, 60, 90 and 100 tablets.

Aluminium foil/PVC blister strips: Pack sizes 10, 20, 28, 30, 50, 56, 60, 90 and 100 tablets.

Not all pack sizes shall be marketed.

Marketing Authorisation Holder and Manufacturer

Strides Pharma UK Ltd.

Unit 4, Metro Centre,

Tolpits Lane, Watford, Herts

WD18 9SS, UK

Tel: 01923 255580

Fax: 01923 255581

This leaflet was last revised in 07/2020.

IO CM 3

ARTWORK DETAIL LABEL

Product	DICLO-SR 75
Buyer/Country	SPUK	Component	Pack Insert
Dimension	180 × 280mm			Pack	–
New Item Code	1041245	Old Item Code	1039998
Colour Shades	BLACK			No. of Colours	1

Change Control No.	Record Number: 264154 Artwork Version 6.0
Design/Style	Front & Back Printing. To be supplied in unfolded size.
Substrate	60 GSM Paper.
Special Instructions	Printing clarity to be clear & sharp.
Autocartonator Requirements	Pack insert supply should be as per auto-cartonator. Refer auto-cartonator drawing for instructions.
Caution to the printer: Before processing, please ensure that the ARTWORK received for printing Is exactly in line with APPROVED ARTWORK provided to you. In case of any FONTS/DESIGN are Mis-matching with the APPROVED ARTWORK, please inform PDC for further action. DO NOT MAKE ANY CHANGE TO THE ARTWORK WITHOUT WRITTEN INSTRUCTIONS FROM PDC.

Use in children:

Diclo-SR 75 is not recommended for use in children.

If you take more Diclo-SR 75 than you should

If you accidently take too many Diclo-SR 75 tablets, tell your doctor at once. If you can’t do this, go to the nearest casualty department. Take along any tablets that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take Diclo-SR 75

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

If you stop taking Diclo-SR 75

Continue to take the tablets for as long as your doctor tells you to. Talk to your doctor if you have any concerns.

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

4. possible side effects

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

Serious side effects:

If you suffer from any of the following side effects, STOP TAKING the tablets and seek immediate medical help:

• – Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

• – Pass blood in your faeces (stools/motions)

• – Pass black tarry stools

• – Vomit any blood or dark particles that look like coffee grounds

• – Indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Medicines such as Diclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If you experience any of the following stop taking the tablets and contact your doctor immediately:

• All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eye lids, face or lips, rash, reddening of the skin or itching (especially affecting your whole body)
• Severe painful skin disorder with blisters and peeling skin. You may also have flu-like symptoms such as fever or sore throat (Stevens-Johnson Syndrome)
• Jaundice with symptoms of yellowing of eyes and skin
• Diarrhoea (stop taking Diclo-SR 75 and do not take it again)
• Blood disorders; you may have a persistent sore throat or high temperature, anaemia (feeling tired after exercising, giddiness, looking pale)
• Respiratory problems: including inflammation of the lungs which causes breathlessness, cough and raised temperature and aggravated asthma
• An unexpected change in the amount of urine produced and/or its appearance.

The side effects listed below have also been reported.

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

• Nausea, vomiting, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.

Uncommon (may affect up to 1 in 100 people):

• Palpitations (fast or irregular heart beat)
• Chest pain
• Heart disorders, including congestive heart failure.

These symptoms are generally associated in those on longterm treatment with a high dose (150mg per day).

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

• Gastritis (inflammation, irritation or swelling of the stomach lining)
• Drowsiness, tiredness
• Fluid retention, symptoms of which include swollen ankles Liver function disorders, including hepatitis
• Raised, itchy rash (Urticaria).