Read all of this leaflet carefully before you starts using this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1. What Doloplus Tablets is and what it is used for
2. Before you use Doloplus Tablet
3. How to use Doloplus Tablet
4. Possible side effects
5. How to store Doloplus Tablet
6. Further information

1. WHAT DOLOPLUS TABLETS IS AND WHAT IT IS USED FOR?

Doloplus tablet is a combination of two medicines: Diclofenac and Paracetamol. This medication helps in relieving pain and inflammation. It works by lowering the levels of chemical substances in the body that cause pain and inflammation. Paracetamol / Acetaminophen has an early onset of action which means that it takes very less time to start its action and it helps in relieving the symptoms till diclofenac starts working.

2. BEFORE YOU TAKE DOLOPLUS TABLET

Do not take Doloplus tablets if you are allergic to diclofenac sodium, aspirin, ibuprofen and Paracetamol or any other NSAID or to any of the ingredients listed in section 6 of this leaflet. Take special care with Doloplus tablet if you have kidney or liver problems, you ever had asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic pulmonary diseases or infections of the respiratory tract. you have diabetes, you have Systemic Lupus Erythematosus SLE (inflammatory, auto-immune disorder which causes symptoms such as joint pain, joint inflammation, skin rashes, fever) or any similar condition. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect the way some other medicines work. Also, some other medicines can affect the way paracetamol works. Any other NSAID or COX-2 (cyclo-oxygenase-2) inhibitor, for example aspirin or ibuprofen, Medicines to treat diabetes, Diuretics, Ciclosporin and tacrolimus, Mifepristone, Quinolone antibiotics. Tacking Doloplus tablet with with food and drink: You should not drink whilst taking these tablets. Taking alcohol with paracetamol can increase your chances of getting side effects. Take this medicine with or after food.

Pregnancy and breast feeding:

Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take Doloplus tablets during the last 3 months of pregnancy as it may affect the baby's circulation. You should advise your doctor or pharmacist if you think you might be pregnant or are up to 6 months pregnant. Taking Doloplus tablets may make it more difficult to become pregnant. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant. You should avoid taking Doloplus tablet whilst breast feeding.

Driving and using machines:Patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac, should refrain from driving or using machines. Paracetamol has no influence on the ability to drive and use machines.

3. HOW TO TAKE DOLOPLUS TABLET

Adult: 2 to 3 tablets daily divided doses. If gastrointestinal complaints occur, Administer Doloplus tablet with meal. Or as directed by the physician. Children: As directed by physician. If you take more Doloplus tablet than you should concerned about an overdose you should consult your doctor or pharmacist, if possible you should take the packaging and this leaflet with you. If you forget to take Doloplus tablet then it is safe to take it at any time before the next dose is due.

4. POSSIBLE SIDE EFFECTS

Possible side effect of Doloplus tablet is Redness of the rectal mucous membranes, allergic reactions, Exanthema, urticarial, liver damage, increase in creatinine, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding / perforation, heartburn, nausea, GI ulcers and vomiting, abnormal renal function, anemia, dissiness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus, Fever, infection sepsis, congestive heart failure, hypertension, tachycardia, syncope dry mouth, esophagitis, gastric/peptic ulcer, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia, anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo, asthma, dyspnea, alopecia, photosensitivity, increased sweating, blurred vision, cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.

5. HOW TO STORE DOLOPLUS TABLET

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

Store in the original package to protect from moisture.

Store in a cool, dry place below 30°C

Do not use this medicine after the expiry date which is stated on the outside packaging and the blister packaging after ‘Do not use after’ or ‘EXP’. A month and a year are shown there. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste, and don't flush them down the toilet. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. FURTHER INFORMATION DOLOPLUS TABLETS

Composition:

Each uncoated tablet contains:

Diclofenac Sodium BP 50 mg (Enteric Coated)

Paracetamol BP 500 mg

They also contain Maize Starch, Lactose, MCC, Magnesium Stearate, Purified Talc & Sodium Starch Glycolate.

What DOLOPLUS TABLETS looks like and contents of the pack:

DOLOPLUS TABLETS

Description: White uncoated caplets with ESKAY embossed on one side & a break line on other side.

The tablets are available in quantities of 10 tablets in blister, packed in 100.

Made in Ghana by:

ESKAY THERAPEUTICS LIMITED

Nungua Industrial Area, Spintex Road

ACCRA-GHANA

[email protected]

This leaflet was last revised in March, 2023

Next Revision Date February, 2028