25 micrograms, 50 micrograms, 75 micrograms, 100 micrograms, 125 micrograms, 150 micrograms, 175 micrograms and 200 micrograms levothyroxine tablets
What Levaxin is and what it is used for
Levaxin replaces missing or decreased production of thyroid hormone ( thyroxine ). Levaxin works in the same way as the body’s own thyroid hormone and is used for impaired thyroid function.
What you need to know before you use Levaxin
Do not use Levaxin
- if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6).
- if you have impaired function of the adrenal glands or the pituitary gland lobe and if these conditions are untreated.
- if you have hypothyroidism ( thyrotoxicosis ).
- together with medicines that counteract the production of thyroid hormone if you are pregnant at the same time (see section Pregnancy and breast-feeding).
Warnings and cautions
Talk to your doctor or pharmacist before using Levaxin
- if you suffer from any heart disease
- if you have impaired adrenal function (adrenal insufficiency)
- if you have diabetes or another hormonal disorder
- whether you are in menopause or after menopause. Your doctor may need to have regular check-ups of thyroid function due to an increased risk of osteoporosis.
Be careful with dosing one to avoid overdose symptoms.
Blood pressure will be monitored regularly when levothyroxine treatment is started in premature infants with very low birth weight as rapid fall in blood pressure (called circulatory collapse) may occur.
Thyroid hormones should not be used to achieve weight loss. Intake of thyroid hormones does not reduce the weight if your thyroid hormone level is within the normal range. Serious or even life-threatening side effects can occur if you increase the dose without consulting your doctor, especially when taken with other weight loss medicines.
There may be an imbalance in the thyroid gland if you need to change your medicine to another medicine containing levothyroxine. Talk to your doctor if you have any questions about changing medications. Close monitoring (clinical examination and laboratory tests) is required during the transition period. Tell your doctor if you get any side effects, as they may cause a dose adjustment.
Other medicines and Levaxin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
The treatment effect may be affected if Levaxin is taken at the same time as certain other medicines.
- Iron supplements, calcium preparations or medicines that contain aluminum and are used, for example, for heartburn, acid reflux or stomach ulcers . It should take four hours between taking these drugs and Levaxin.
- Some medicines (for diabetes ) are used to lower blood sugar levels.
- Digitalis glycosides used in heart disease.
- Some cholesterol lowering agents such as cholestyramine and cholestipol. There should be at least four hours between taking these drugs and Levaxin.
- Polystyrene sulfonate used in the treatment of elevated blood potassium levels ( hyperkalaemia ). There should be at least four hours between taking these drugs and Levaxin.
- Warfarin which is a drug that counteracts blood clots.
- Sertraline which is a medicine for depression.
- Imatinib which is a medicine for blood cancer.
- Rifampicin and rifapentin which are antibiotics for infection .
- Estrogen is (found, for example, in certain contraceptives or in medicines used for menopausal symptoms).
- Protease inhibitors (such as ritonavir and lopinavir) used to control HIV – virus and chronic hepatitis C virus .
- Sevelamer used to treat patients with chronic kidney failure .
- Beta-blockers, which are antihypertensive drugs that are also used to treat heart disease.
- Chloroquine or proguanil, which are medicines to prevent and treat malaria , among other things .
- Propylthiouracil which is a drug that inhibits the production of thyroid hormone.
- Glucocorticoids (eg cortisone ) used to treat allergies and inflammation .
- Contrast agent containing iodine given in connection with X-ray examination.
- Amoidarone used to treat certain heart problems.
- Carbamazepine, a medicine used to treat epilepsy .
- Barbiturate you who are sedatives.
Levaxin with food
In the event of a significant change in the amount of soy products in the food, dose one of Levaxin may need to be adjusted.
Pregnancy and breastfeeding
Pregnancy
No adverse effects on the fetus have been demonstrated. However, consult a doctor as soon as pregnancy is diagnosed as the dose often needs to be changed.
If you are pregnant and taking medicines that counteract the production of thyroid hormone, your doctor may discontinue your Levaxin treatment.
Breast-feeding
Levaxin passes into breast milk but is unlikely to affect breast-fed infants. However, consult a physician if more than temporary use of Levaxin during breast-feeding.
Driving and using machines
No known effect on the ability to drive or perform precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Levaxin contains lactose
The tablets contain 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.
How to use Levaxin
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
Swallow the tablet with a little water. The medicine should preferably be taken 30 minutes before breakfast, as food can affect the absorption of the medicine in the body, but the most important thing is that you have the same routines every day so that dose one can be adjusted to your habits.
In the event of a significant change in your eating habits, your Levaxin dose may need to be adjusted. Talk to your doctor.
All strengths except 25 micrograms are equipped with a break notch and can be divided into two equal doses .
Place the tablet on a hard, flat surface with the notch facing up. Break the tablet by pressing the tablet downwards with your index finger.
If necessary, the tablet can be dissolved in a little water (10-15 ml). The solution is diluted with additional liquid (5-10 ml) and should then be taken immediately.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Stop taking Levaxin and contact a doctor immediately if you get any of the following symptoms ( angioedema , occurring in an unknown number of users): swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing.
Less common side effects are (may affect up to 1 in 100):
Transient hypothyroidism after treatment.
Has been reported (occurs in an unknown number of users):
Allergic skin reactions, weight loss, anxiety, difficulty sleeping, headaches, tremors, effects on heart rhythm, angina, diarrhea, vomiting, muscle cramps, muscle weakness, menstrual disorders, hemorrhage, fever, increased sweating. Patients with a cardiovascular disease may deteriorate in their underlying disease.
In case of overdose or if the dose is increased too fast, the same symptoms as with elevated thyroid hormone levels in the body can occur. Many of the side effects listed above are caused by such symptoms.
How to store Levaxin
Plastic jar : Do not store above 25 ° C.
Blister : Do not store above 25 ° C in the original package. Sensitive to light.
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 carton. Expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Empty drug packages are sorted at source according to local regulations.
Contents of the pack and other information
Content declaration
- The active substance is levothyroxine sodium corresponding to levothyroxine 25 micrograms, 50 micrograms, 75 micrograms, 100 micrograms, 125 micrograms, 150 micrograms, 175 micrograms and 200 micrograms per tablet, respectively.
- The other ingredients are lactose monohydrate 44 mg, 88 mg, 133 mg,67 mg, 84 mg, 100 mg, 117 mg and 134 mg, respectively, corn starch,gelatin (porcine origin), magnesium stearate, talc.
What the medicine looks like and contents of the pack
The tablets are round, white and marked with the strength expressed in micrograms (25, 50, 75, 100, 125, 150, 175 and 200 respectively).
All strengths except 25 micrograms are equipped with a break notch and can be divided into two equal doses .
Levaxin is supplied in a plastic jar with a child-resistant lid and pressure packaging.
An explanation of how to open the jar can be found on the jar lid:
The arrows should be aimed at each other on the can lid and can, then the lid can be pushed upwards.
To close the jar, push the lid back on. In order for the jar to be child-protective again, the arrows must be separated on the lid and jar, respectively.
Pack sizes:
25, 50, 100, 150 microgram tablets : 98×1 (single dose blister), 100 (plastic jar) and 250 (plastic jar)
75, 175, 200 microgram tablets : 98×1 (single dose blister) and 100 (plastic jar)
125 micrograms tablets : 100 (plastic jar) and 250 (plastic jar)
Not all pack sizes may be marketed.