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INTRODUCTION ABOUT FLORINA L TABLET
FLORINA L TABLET contains Levonorgestrel, which belongs to the group of medicines called Emergency Contraceptives. It is used to manage pregnancy. It is recommended for use by women only in the event of an emergency following an event of unprotected sexual intercourse or failure of birth control measures. However, it is not recommended for regular usage as a contraceptive.
FLORINA L TABLET is not recommended for use in patients with severe liver problems, Crohn’s disease (an inflammatory small bowel disease), a history of ectopic pregnancy (a condition where the baby develops elsewhere outside of the womb), salpingitis (inflammation of the fallopian tubes), thrombosis (blood clotting) or serious digestive problems.
FLORINA L TABLET is not recommended for use in pregnant women, as it does not terminate the pregnancy. FLORINA L TABLET should be used with caution in breastfeeding mothers as it may pass through breast milk. Avoid nursing your baby for the next 8 hours after taking FLORINA L TABLET and your doctor may also recommend draining the breast milk (before nursing your baby) after taking this medicine. FLORINA L TABLET is not recommended for use by children who have not attained puberty.
The most common side effects of taking FLORINA L TABLET are nausea, irregular bleeding until the next menstrual cycle, lower abdominal pain, tiredness, headache, vomiting, tender breasts, diarrhoea and feeling dizzy. Contact your doctor immediately if any of your symptoms get worse or persist.
USES OF FLORINA L TABLET
- To manage pregnancy
HOW FLORINA L TABLET WORKS
FLORINA L TABLET works by managing the release and fertilization (when sperm unite with an egg) or of the egg from the ovary or by managing the attachment of a fertilized egg to the uterus (implantation).
DIRECTIONS FOR USE
Take FLORINA L TABLET as advised by your physician. Take FLORINA L TABLET within 72 hours after unprotected sexual intercourse. Swallow the medicine with water and do not crush or chew the medicine.
SIDE EFFECTS OF FLORINA L TABLET
COMMON
- nausea, vomiting
- lower abdominal pain, diarrhoea
- irregular bleeding until the next menstrual cycle
- tiredness
- headache, feeling dizzy
- tender breasts
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take the medicine with or just after a meal. Stick to simple meals. Avoid eating oily or spicy foods. If your symptom gets worse or persist, consult your doctor immediately.
Stomach pain:
Try to rest and relax. Eat small meals but take them frequently. Keep a heating pad on your stomach. If your symptom gets worse or persist, consult your doctor immediately.
Diarrhoea:
Drink plenty of water and fruit juice, to keep yourself hydrated. Contact your doctor if the symptom does not improve.
Headache:
Rest and relax. If necessary, apply a pain-relieving balm to your forehead. Contact your doctor if the headache does not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Contact your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
FLORINA L TABLET is not recommended for use by pregnant women. FLORINA L TABLET does not help to terminate the pregnancy. If you happen to get pregnant after taking FLORINA L TABLET, contact your doctor immediately.
BREASTFEEDING
FLORINA L TABLET should be used with caution in breastfeeding mothers as it may pass through breast milk. Avoid nursing your baby for the next 8 hours after taking this medicine. Your doctor may also recommend draining the breast milk (before nursing your baby) after taking this medicine. Contact your doctor before taking FLORINA L TABLET.
DRIVING AND USING MACHINES
Do not drive or operate machines if you feel tired or dizzy after taking FLORINA L TABLET.
LIVER
FLORINA L TABLET is not recommended for use in patients with severe liver disease or liver cancer. Contact your doctor before taking FLORINA L TABLET.
ALLERGY
Do not take FLORINA L TABLET if you are allergic (hypersensitive) to levonorgestrel or have an intolerance to lactose or other ingredients in this medicine.
LUNGS
FLORINA L TABLET is not recommended for use in patients with lung disease, such as pulmonary embolism (blood clots in the lung). Contact your doctor before taking FLORINA L TABLET.
HEART DISEASE
FLORINA L TABLET is not recommended for use in patients with heart diseases, such as myocardial infarction and angina. Contact your doctor before taking FLORINA L TABLET.
OTHERS
FLORINA L TABLET is not recommended for use if you have:
- crohn’s disease (an inflammatory small bowel disease)
- a history of ectopic pregnancy (a condition where the baby develops somewhere outside of the womb)
- a history of salpingitis (inflammation of the fallopian tubes)
- previous ectopic pregnancy or salpingitis may increase the risk of a new ectopic pregnancy
- known risk factor for thrombosis (blood clotting) in your family or personal history
- serious digestive problems (that make it difficult to properly absorb both food and medication)
- blood clot in the veins, e.g., in the veins supplying the leg (deep venous thrombus)
- diabetes mellitus
- breast cancer or genital cancer
- undiagnosed vaginal bleeding
Before taking FLORINA L TABLET, inform your doctor if you
- have HIV or AIDS
- have unusual bleeding before your regular menstrual cycle or if there is a delay in your menstrual cycle (more than 5 days)
- had unprotected sex 3 days before
Use in paediatrics:
FLORINA L TABLET is not recommended for use in children who have not attained puberty (adulthood). Contact your doctor before taking FLORINA L TABLET.
Use in geriatrics:
FLORINA L TABLET is not recommended for use in postmenopausal women. Contact your doctor before taking FLORINA L TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking FLORINA L TABLET, inform your doctor if you are taking any of the following medicine:
- barbiturates and other medicines used to manage epilepsy (Ex. phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate and felbamate)
- medicines used to manage tuberculosis (Ex. rifabutin, rifampicin)
- medicines used to manage HIV (Ex. ritonavir, efavirenz)
- medicine used to manage fungal infections (Ex. griseofulvin)
- St John’s wort (a medicine used for depression)
- cyclosporin (a medicine used to suppress the immune system)
- ulipristal acetate (a medicine used to manage uterine fibroids)
- medicine used to manage fungal infections (Ex. griseofulvin)
- bosentan (medicines used to manage pulmonary arterial hypertension)
Overdosage:
If you or anyone else has accidentally taken too much of FLORINA L TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose may include vomiting (being sick), nausea, vaginal bleeding, etc.
SYNOPSIS
| Drug | : | Levonorgestrel |
| Pharmacological Category | : | Emergency Contraceptives |
| Therapeutic Indication | : | To manage pregnancy |
| Dosage Forms | : | Tablet, Kit, Injection, Intra Uterine Device |
MORE INFORMATION
- Keep FLORINA L TABLET out of the sight and reach from children
- Store FLORINA L TABLET below 25°C
FAQs ABOUT FLORINA L TABLET
What is FLORINA L TABLET used for?
FLORINA L TABLET is used as an emergency contraceptive to manage pregnancy after unsafe sexual intercourse (such as failure of contraceptives or taking birth control measures). It should be used within 72 hours after having unprotected sexual intercourse and it would be effective if you took this medicine within 12 hours rather than delay. It is not recommended to use this medicine as a regular birth control measure.
How does FLORINA L TABLET work?
FLORINA L TABLET works by managing the release and fertilization (when sperm unite with an egg) or of the egg from the ovary or by managing the attachment of a fertilized egg to the uterus (implantation).
Can FLORINA L TABLET affect my menstrual cycle?
FLORINA L TABLET can affect your regular menstrual cycle. If you experience a delay or irregular menstrual bleeding, consult your doctor immediately.
What are the side effects of taking FLORINA L TABLET?
The most common side effects of taking FLORINA L TABLET are nausea, irregular menstrual bleeding till your next cycle, lower abdominal pain, tiredness, headache, vomiting, tender breasts, diarrhoea and feeling dizzy. Contact your doctor if your symptoms get worse or persist.
How often can you use FLORINA L TABLET?
FLORINA L TABLET is not recommended for regular use. It is less effective and more likely to disturb your menstrual cycle if FLORINA L TABLET is used more than once throughout a menstrual cycle (period).
REFERENCES
1. K D Tripathi. Estrogens, Progestins and Contraceptives. Essentials of medical pharmacology. 7th edition. 2013. Page – 322.
2. Christina Vrettakos, Tushar Bajaj. Levonorgestrel. National Institute of Health. NLM. National Centre for Biotechnology Information. Stat Pearls. May 2022. [Accessed on 6th August 2022] https://www.ncbi.nlm.nih.gov/books/NBK539737/
3. Lupin Healthcare (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in October 2021] [Accessed on 6th August 2022] https://www.medicines.org.uk/emc/files/pil.7308.pdf
4. Delpharm lille SAS. Health Products Regulatory Authority (HPRA). [Revised in June 2017] [Accessed on 6th August 2022] https://www.hpra.ie/img/uploaded/swedocuments/PIL-2194006-28062017105522-636342441250781250.pdf
5. Gedeon Richter, Ltd. U.S. Food & Drug Administration. [Revised in July 2009] [Accessed on 6th August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf
6. Laboratorios León Farma S.A. Levonorgestrel. [Revised in December 2019] [Accessed on 6th August 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=626a2333-ff56-ef28-a287-b33bacc0302a&type=display
7. Mylan Laboratories Limited. Levonorgestrel. [Revised in February 2017] [Accessed on 6th August 2022] https://extranet.who.int/pqweb/sites/default/files/RH031part3v1.pdf
8. HLL Lifecare Limited. Levonorgestrel. [Revised in July 2018] [Accessed on 6th August 2022] https://extranet.who.int/pqweb/sites/default/files/RH065part3v1.pdf



